Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Rotavirus Vaccine, Live, Oral, Pentavalent
Hepatitis B Vaccine* [Recombinant] *as applicable
Countries
United States
Canada
Honduras
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT04398706
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PSK00008
Secondary IDs
ID
Type
Description
Link
U1111-1238-1638
Registry Identifier
ICTRP
PSK00008
Other Identifier
Sanofi Identifier
Brief Title
Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
Official Title
Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
Acronym
Not provided
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Sep 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 22, 2020Actual
Primary Completion Date
Aug 10, 2023Actual
Completion Date
Aug 10, 2023Actual
First Submitted Date
May 18, 2020
First Submission Date that Met QC Criteria
May 19, 2020
First Posted Date
May 21, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Aug 9, 2024
Results First Submitted that Met QC Criteria
Nov 7, 2024
Results First Posted Date
Nov 12, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 4, 2025
Last Update Posted Date
Sep 8, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sanofi Pasteur, a Sanofi CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Primary objectives:
To assess the safety profile of each SP0202 formulation and Prevnar 13 in toddlers and infants (after each and any injection).
To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4)
To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in infants (Groups 5-8)
To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in infants (Groups 5-8)
Secondary objectives:
To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4)
To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in a subset of infants (Groups 5-8)
To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in a subset of infants (Groups 5-8)
In toddlers: to describe the Ab responses against Pentacel antigens before and 1 month following injection of Pentacel
In infants: to describe the Ab responses against antigens of the routine pediatric vaccines (Pentacel, RotaTeq, ENGERIX-B, M-M-RII, and VARIVAX) when administered concomitantly with either SP0202 or Prevnar 13 (at pre-Dose 1 (as applicable) for RotaTeq, Diphteria, Tetanus and Pertussis antigens; at PD3 for ENGERIX-B, RotaTeq, and Pentacel; at PD4 for M-M-RII and VARIVAX])
Detailed Description
For toddlers, the duration of each participant's participation in the study will be approximately 6 months for subjects enrolled in Groups 1, 2, 3, and 4.
For infants, the duration of each participant's participation in the study will be approximately 16 to 19 months for subjects enrolled in Groups 5, 6, 7, and 8.
Conditions Module
Conditions
Pneumococcal Immunisation
Diphtheria Immunisation
Tetanus Immunisation
Pertussis Immunisation
Hepatitis B Immunisation
Haemophilus Influenzae Type b Immunisation
Polio Immunisation
Measles Immunisation
Rubella Immunisation
Varicella Immunisation
Mumps Immunisation
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
852Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1
Experimental
One dose of SP0202-IIb and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Group 2
Experimental
One dose of SP0202-VI and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Group 3
Experimental
One dose of SP0202-VII and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Group 4
Active Comparator
One dose of Prevnar 13 and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pneumococcal Conjugate Vaccine formulation 1
Biological
Pharmaceutical form:liquid Route of administration: intramuscular
Group 1
Group 5
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Immediate Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. Immediate events were recorded to capture medically relevant unsolicited systemic AEs (including those related to the product administered) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination and included both serious adverse events (SAEs) and non-serious unsolicited AEs.
Up to 30 minutes after each vaccination
Number of Participants With Solicited Injection Site Reactions
A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRB and were considered to be related to the product administered. An injection site reaction was an adverse reaction at and around the injection site which were commonly inflammatory reactions. Solicited injection site reactions included tenderness, erythema and swelling around the injection site and were planned to be collected and reported for SP0202/Prevnar 13 for both toddlers and infants.
Up to 7 days after each vaccination
Number of Participants With Solicited Systemic Reactions
A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability. Reported AEs for each arm were presented as pre-specified in protocol.
Up to 7 days after each vaccination
Number of Participants With Unsolicited AEs
An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product, and which did not necessarily have a causal relationship with this treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs included both SAEs and non-serious unsolicited AEs. Reported AEs for each arm were presented as pre-specified in protocol.
Secondary Outcomes
Measure
Description
Time Frame
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose
The GMs for serotype specific OPA titers were measured using multiplex opsonophagocytic assay (MOPA) which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.
Day 30
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria :
Toddlers and infants:
Participant and parent/guardian are able to attend all scheduled visits and to comply with all study procedures
Born at full term of pregnancy (≥ 37 weeks) and/or with a birth weight ≥ 5.5 lbs or 2.5 kg
Specifically for toddlers:
Aged 12 to 15 months on the day of the first study visit
Participant has received 3 doses of Prevnar 13 and 3 doses of diphteria, tetanus, acellular pertussis, poliovirus and Haemophilus influenzae type b antigens in infancy
Specifically for infants:
- Aged 42 to 89 days on the day of the first study visit
Exclusion criteria:
Toddlers and infants
Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated
Blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
Active tuberculosis
History of S. pneumoniae infection or disease, confirmed either serologically or microbiologically
History of any neurologic disorder, including any seizures and progressive neurologic disorders
Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the Investigator's opinion
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion
Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and know congenital or genetic diseases) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives
In an emergency setting, or hospitalized involuntarily
Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C / ≥ 100.4 F). A prospective participant should not be included in the study until the condition has resolved or until 3 days after the febrile event has resolved
Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study Specifically for toddlers
Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 2), except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
Receipt of immune globulins, blood or blood-derived products in the past 3 months
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
History of diphtheria, tetanus, pertussis, poliomyelitis, and/or H. influenzae type b infection or disease Specifically for infants
Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 6), except for influenza vaccination or COVID-19 vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, and COVID-19 vaccines as applicable per local recommendations
Receipt of immune globulins, blood or blood-derived products since birth.
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth
Previous vaccination against S. pneumoniae
Previous vaccination against the following antigens: diphteria, tetanus, pertussis, H. influenzae type b, poliovirus, rotavirus, measles, mumps, rubella, and varicella
Receipt of more than 1 previous dose of hepatitis B vaccine
History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, measles, mumps, rubella, varicella, H. influenzae type b, and/or rotavirus infection or disease
History of intussusception
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
42 Days
Maximum Age
15 Months
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Sciences & Operations
Sanofi Pasteur, a Sanofi Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
The Children's Clinic Of Jonesboro PA Site Number : 8400143
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 140 participants were randomized in Stage I and 712 participants were randomized in Stage II of study.
Recruitment Details
The Stage I of study was conducted at 22 active centers in the US between 22 May 2020 and 10 March 2021. The Stage II of study was conducted at 35 active centers in the US, Canada and Honduras between 16 April 2021 and 24 February 2022.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Stage I: Group 1 SP0202-IIb
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.
FG001
Stage I: Group 2 SP0202-VI
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 4, 2022
Aug 9, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
The study will be performed in a modified double-blind fashion:
Investigators and study staff who conduct the safety assessment and the participant will not know which vaccine is administered
Only the study staff who prepare and administer the vaccine and are not involved with the safety evaluation will know which vaccine is administered This study will be observer-blinded between any SP0202 formulation and Prevnar 13 and double-blind across the 3 SP0202 formulations
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Group 5
Experimental
Four doses of SP0202-IIb at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Biological: Hepatitis B Vaccine* [Recombinant] *as applicable
Group 6
Experimental
Four doses of SP0202-VI at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Biological: Hepatitis B Vaccine* [Recombinant] *as applicable
Group 7
Experimental
Four doses of SP0202-VII at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Biological: Hepatitis B Vaccine* [Recombinant] *as applicable
Group 8
Active Comparator
Four doses of Prevnar 13 at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Biological: Varicella Virus Vaccine Live
Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
Group 4
Group 8
Prevnar 13®
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Biological
Pharmaceutical form:liquid Route of administration: intramuscular
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6
Group 7
Group 8
DTaP-IPV// Hib vaccine, Pentacel®
Rotavirus Vaccine, Live, Oral, Pentavalent
Biological
Pharmaceutical form:liquid Route of administration: oral
Group 5
Group 6
Group 7
Group 8
Rotavirus vaccine, RotaTeq
Hepatitis B Vaccine* [Recombinant] *as applicable
Biological
Pharmaceutical form:liquid Route of administration: intramuscular
Group 5
Group 6
Group 7
Group 8
Hepatitis B vaccine, ENGERIX-B®
Up to 30 days after each vaccination
Number of Participants With SAEs and Adverse Event of Special Interest (AESIs)
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. The following AE were captured as AESI throughout the study: Anaphylaxis defined as per the Brighton collaboration case definition, convulsions including febrile convulsions, hypotonic-hyporesponsive episode and apnea. Reported AEs for each arm were presented as pre-specified in protocol.
From first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose
The GMCs for serotype specific pneumococcal IgG antibodies were measured using pneumococcal capsular polysaccharide-electro-chemiluminescent assay (PnPS-ECL), a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Day 30
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3
Percentage of infants with serotype specific IgG concentration >=0.35 mcg/mL for each pneumococcal serotype included in the SP0202 formulations were measured using ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Day 150
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3
The GMCs for serotype-specific pneumococcal IgG antibodies were measured using PnPS-ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Day 150
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4
The GMCs for serotype specific pneumococcal IgG antibodies were measured using PnPS-ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Day 330
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3
The GMs for serotype specific OPA titers were measured using MOPA which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.
Day 150
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4
The GMs for serotype specific OPA titers were measured using MOPA which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.
Day 330
For Infants: GMC of Anti-Rotavirus Serum Immunoglobulin A (IgA) Antibodies 30 Days Post-Dose 3
Anti-rotavirus IgA antibodies in human serum were measured by enzyme linked immunosorbent assay (ELISA). A reference standard assayed on each plate was used to calculate the amount of specific anti-rotavirus IgA antibody in the units assigned by the reference standard.
Day 150
For Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3
Percentage of participants with toxoid concentration >=0.10 mcg/mL for diphtheria and tetanus and >=0.15 mcg/mL for PRP are presented. Anti-diphtheria and anti-tetanus concentrations were measured using electro-chemiluminescence assay (ECL) and anti-PRP concentrations were measured using a Farr-type radioimmunoassay.
Day 150
For Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3
Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Response was defined as a titer >=8.
Day 150
For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3
Serum samples were collected for analysis by ECL to determine the GMC of antibodies to the following Pertussis antigens: Pertussis toxoid/toxin, Filamentous hemagglutinin, Pertactin and Fimbriae types 2 and 3.
Day 150
For Infants: Percentage of Participants With Antibody Responses to Hepatitis-B Antigens 30 Days Post-Dose 3
Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ immunodiagnostic system using chemiluminescence detection technology. The VITROS ECi immunodiagnostic system uses an antibody mediated antigen sandwich formation to detect the presence of anti-hepatitis B surface antigen total immunoglobulin in human serum. The threshold presented is >=10 milli international units (mIU).
Day 150
For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4
Anti-measles antibodies were determined by bulk measles IgG enzyme immunoassay (EIA); anti-mumps antibodies by ELISA, anti-rubella antibodies by bulk rubella IgG EIA and anti-varicella antibodies were determined by glycoprotein ELISA to detect total IgG antibody to respective virus before and after vaccination with a virus-containing vaccine. Percentage of participants with anti-measles antibody concentrations >=255 mIU/mL, anti-mumps antibody concentrations: >=10 antibody units/mL, anti-rubella antibody concentrations >=10 IU/mL and anti-varicella concentrations >=5 units/mL is reported in this outcome measure.
Day 330
Southland Clinical Research Center Site Number : 8400040
Bellflower
California
90706
United States
Joint Clinical Trials Huntington Park Site Number : 8400030
Huntington Park
California
90255
United States
Matrix Clinical Research Huntington Park Site Number : 8400058
Huntington Park
California
90255
United States
Matrix Clinical Research Site Number : 8400059
Los Angeles
California
90057
United States
Orange County Research Institute Site Number : 8400060
Ontario
California
91762
United States
California Research Foundation Site Number : 8400052
San Diego
California
92123-1881
United States
Meridian Clinical Research Washington DC Site Number : 8400119
Washington D.C.
District of Columbia
20016
United States
International Research Partners, LLC Site Number : 8400077
Doral
Florida
33122
United States
Homestead Medical Clinic, P.A. Site Number : 8400032
Homestead
Florida
33030
United States
Dade Research Center Site Number : 8400122
Miami
Florida
33135
United States
Miami Clinical Research Site Number : 8400020
Miami
Florida
33155
United States
Amber Clinical Research, LLC Site Number : 8400019
Miami
Florida
33164
United States
Jedidiah Clinical Research Site Number : 8400049
Tampa
Florida
33617
United States
Javara Albany Site Number : 8400140
Albany
Georgia
31707
United States
Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400062
Columbus
Georgia
31904
United States
Javara Fayetteville Site Number : 8400139
Fayetteville
Georgia
30214
United States
Dumog Research Site Number : 8400134
Smyrna
Georgia
30080
United States
Bingham Memorial Hospital Site Number : 8400067
Blackfoot
Idaho
83221
United States
Leavitt Clinical Research Site Number : 8400127
Idaho Falls
Idaho
83404
United States
Hutchinson Clinic Site Number : 8400074
Hutchinson
Kansas
67502
United States
Qualmedica Research, LLC Site Number : 8400084
Bowling Green
Kentucky
42101
United States
Michael W. Simon, MD, PSC Site Number : 8400002
Lexington
Kentucky
40517
United States
Meridian Clinical Research, LLC Site Number : 8400112
Baton Rouge
Louisiana
70806
United States
Benchmark Research Site Number : 8400012
Covington
Louisiana
70433
United States
Velocity Clinical Research Lafayette Site Number : 8400132
Lafayette
Louisiana
70508
United States
Javara Annapolis Site Number : 8400137
Annapolis
Maryland
21401
United States
Javara Chevy Chase Site Number : 8400138
Chevy Chase
Maryland
20815
United States
Children's Mercy Hospital Site Number : 8400008
Kansas City
Missouri
64108
United States
Boeson Research Site Number : 8400004
Missoula
Montana
59804
United States
Meridian Clinical Research Site Number : 8400102
Grand Island
Nebraska
68803
United States
Lincoln Pediatric Group Site Number : 8400125
Lincoln
Nebraska
68516
United States
Pediatric Infectious Diseases Research Site Number : 8400104
Omaha
Nebraska
68131
United States
Atrium Health Site Number : 8400124
Charlotte
North Carolina
28204
United States
Ardmore Medical Research Site Number : 8400043
Winston-Salem
North Carolina
27103
United States
Pediatric Associates of Mt. Carmel Site Number : 8400005
Cincinnati
Ohio
45245
United States
Cheraw Pediatrics Site Number : 8400017
Cheraw
South Carolina
29520
United States
Tribe Clinical Research Site Number : 8400025
Greenville
South Carolina
29607
United States
Javara Dallas Site Number : 8400135
Dallas
Texas
75230
United States
Pininos Pediatric Services Site Number : 8400121
El Paso
Texas
79902
United States
North Texas Clinical Trials Site Number : 8400015
Fort Worth
Texas
76104
United States
Houston Clinical Research Associates Site Number : 8400023
Houston
Texas
77090
United States
FMC Science, LLC Site Number : 8400086
Lampasas
Texas
76550-1820
United States
DCOL Center for Clinical Research Site Number : 8400107
Longview
Texas
75605
United States
Biopharma Informatic Site Number : 8400066
McAllen
Texas
78503
United States
Benchmark Research San Antonio Site Number : 8400129
San Antonio
Texas
78201
United States
Sun Research Institute Site Number : 8400011
San Antonio
Texas
78205
United States
Tekton Research Site Number : 8400076
San Antonio
Texas
78244
United States
MultiCare Institute for Research & Innovation Site Number : 8400024
Spokane
Washington
99202
United States
Investigational Site Number : 1240002
Vancouver
British Columbia
V5Z4H4
Canada
Investigational Site Number : 1240001
Halifax
Nova Scotia
B3K6R8
Canada
Investigational Site Number : 1240006
Hamilton
Ontario
L8M 1K7
Canada
Investigational Site Number : 3400002
Municipio Del Distrito Central
11101
Honduras
Investigational Site Number : 3400001
San Pedro Sula
21104
Honduras
Investigational Site Number : 6300002
Bayamón
00961
Puerto Rico
Investigational Site Number : 6300004
Guayama
000784
Puerto Rico
Investigational Site Number : 6300001
San Juan
00935
Puerto Rico
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.
FG002
Stage I: Group 3 SP0202-VII
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.
FG003
Stage I: Group 4 Prevnar 13
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.
FG004
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age [that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII (measles, mumps, and rubella) and Varivax at 12 to 15 months of age].
FG005
Stage II: Group 6 SP0202-VI
Infants aged 2 months received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
FG006
Stage II: Group 7 SP0202-VII
Infants aged 2 months received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
FG007
Stage II: Group 8 Prevnar 13
Infants aged 2 months received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
FG00035 subjects
FG00135 subjects
FG00235 subjects
FG00335 subjects
FG004179 subjects
FG005178 subjects
FG006179 subjects
FG007176 subjects
COMPLETED
FG00035 subjects
FG00131 subjects
FG00232 subjects
FG00332 subjects
FG004148 subjects
FG005147 subjects
FG006151 subjects
FG007160 subjects
NOT COMPLETED
FG0000 subjects
FG0014 subjects
FG0023 subjects
FG0033 subjects
FG00431 subjects
FG00531 subjects
FG00628 subjects
FG00716 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG004
Withdrawal by parent/guardian
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
FG004
Protocol deviation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Stage I: Group 1 SP0202-IIb
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.
BG001
Stage I: Group 2 SP0202-VI
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.
BG002
Stage I: Group 3 SP0202-VII
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.
BG003
Stage I: Group 4 Prevnar 13
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.
BG004
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
BG005
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
BG006
Stage II: Group 7 SP0202-VII
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
BG007
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00035
BG00135
BG00235
BG00335
BG004179
BG005178
BG006179
BG007176
BG008852
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0001.1± 0.11
BG0011.1± 0.10
BG0021.1± 0.12
BG003
Sex/Gender, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00017
BG00112
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0002
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Immediate Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. Immediate events were recorded to capture medically relevant unsolicited systemic AEs (including those related to the product administered) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination and included both serious adverse events (SAEs) and non-serious unsolicited AEs.
Analysis was performed on the Safety analysis set (SafAS) that included all participants who received at least 1 dose of the study vaccines and had any safety data available. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Posted
Count of Participants
Participants
No
Up to 30 minutes after each vaccination
ID
Title
Description
OG000
Stage I: Group 1 SP0202-IIb
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.
OG001
Stage I: Group 2 SP0202-VI
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.
OG002
Stage I: Group 3 SP0202-VII
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.
OG003
Stage I: Group 4 Prevnar 13
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.
OG004
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG005
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG00035
OG00134
OG00235
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Solicited Injection Site Reactions
A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRB and were considered to be related to the product administered. An injection site reaction was an adverse reaction at and around the injection site which were commonly inflammatory reactions. Solicited injection site reactions included tenderness, erythema and swelling around the injection site and were planned to be collected and reported for SP0202/Prevnar 13 for both toddlers and infants.
Analysis was performed on SafAS. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis. Only participants with data collected for each specified category are reported.
Posted
Count of Participants
Participants
No
Up to 7 days after each vaccination
ID
Title
Description
OG000
Stage I: Group 1 SP0202-IIb
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.
OG001
Stage I: Group 2 SP0202-VI
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.
Primary
Number of Participants With Solicited Systemic Reactions
A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability. Reported AEs for each arm were presented as pre-specified in protocol.
Analysis was performed on SafAS. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis. Only participants with data collected for this outcome measure are reported.
Posted
Count of Participants
Participants
No
Up to 7 days after each vaccination
ID
Title
Description
OG000
Stage I: Group 1 SP0202-IIb
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.
OG001
Stage I: Group 2 SP0202-VI
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.
OG002
Primary
Number of Participants With Unsolicited AEs
An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product, and which did not necessarily have a causal relationship with this treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs included both SAEs and non-serious unsolicited AEs. Reported AEs for each arm were presented as pre-specified in protocol.
Analysis was performed on SafAS. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Posted
Count of Participants
Participants
No
Up to 30 days after each vaccination
ID
Title
Description
OG000
Stage I: Group 1 SP0202-IIb
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.
OG001
Stage I: Group 2 SP0202-VI
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.
OG002
Primary
Number of Participants With SAEs and Adverse Event of Special Interest (AESIs)
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. The following AE were captured as AESI throughout the study: Anaphylaxis defined as per the Brighton collaboration case definition, convulsions including febrile convulsions, hypotonic-hyporesponsive episode and apnea. Reported AEs for each arm were presented as pre-specified in protocol.
Analysis was performed on SafAS. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
Posted
Count of Participants
Participants
No
From first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days
ID
Title
Description
OG000
Stage I: Group 1 SP0202-IIb
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.
OG001
Primary
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose
The GMCs for serotype specific pneumococcal IgG antibodies were measured using pneumococcal capsular polysaccharide-electro-chemiluminescent assay (PnPS-ECL), a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Per protocol analysis set 1 (PPAS1) was a subset of Full analysis set (FAS)1. FAS1: All randomized participants to Groups 1 to 4 who received at least 1 dose of study vaccine and had a valid post vaccination blood sample result [serotype specific IgG concentration or serotype specific opsonophagocytic activity (OPA) titer for at least 1 serotype, or titer/concentration for at least 1 antigen on concomitant vaccines]. Only participants with data collected for each specified category are reported.
Posted
Geometric Mean
95% Confidence Interval
microgram/millilitre (mcg/mL)
Day 30
ID
Title
Description
OG000
Stage I: Group 1 SP0202-IIb
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.
OG001
Stage I: Group 2 SP0202-VI
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.
Primary
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3
Percentage of infants with serotype specific IgG concentration >=0.35 mcg/mL for each pneumococcal serotype included in the SP0202 formulations were measured using ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Per protocol analysis set 2 (PPAS2) was a subset of FAS2. FAS2: All randomized participants to Groups 5 to 8 who received at least 1 dose of study vaccine in primary series and had a valid post-primary series vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least 1 serotype, or titer/concentration for at least 1 antigen on concomitant vaccines). Only participants with data collected for each specified category are reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 150
ID
Title
Description
OG000
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG001
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Primary
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3
The GMCs for serotype-specific pneumococcal IgG antibodies were measured using PnPS-ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
PPAS2 was a subset of FAS2. FAS2: All randomized participants to Groups 5 to 8 who received at least 1 dose of study vaccine in primary series and had a valid post-primary series vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least 1 serotype, or titer/concentration for at least 1 antigen on concomitant vaccines). Only participants with data collected for each specified category are reported.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
Day 150
ID
Title
Description
OG000
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG001
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Primary
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4
The GMCs for serotype specific pneumococcal IgG antibodies were measured using PnPS-ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Per protocol analysis set 3 (PPAS3) was a subset of Full analysis set 3 (FAS3). FAS3: All randomized participants to Groups 5 to 8 who received at least 1 dose of study vaccine at time of booster and had a valid post-booster vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least 1 serotype or titer/concentration for at least 1 antigen on concomitant vaccines). Only participants with data collected for each specified category are reported.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
Day 330
ID
Title
Description
OG000
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG001
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Secondary
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose
The GMs for serotype specific OPA titers were measured using multiplex opsonophagocytic assay (MOPA) which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.
Results are based on PPAS1 which is a subset of the FAS1 for toddlers. Only participants with data collected for each specified category are reported.
Posted
Geometric Mean
95% Confidence Interval
1/dilution (1/dil)
Day 30
ID
Title
Description
OG000
Stage I: Group 1 SP0202-IIb
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.
OG001
Stage I: Group 2 SP0202-VI
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.
OG002
Stage I: Group 3 SP0202-VII
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.
Secondary
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3
The GMs for serotype specific OPA titers were measured using MOPA which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.
Results are based on PPPAS2-OPA subset which is a subset of the FAS for infants. Only participants with data collected for each specified category are reported.
Posted
Geometric Mean
95% Confidence Interval
1/dil
Day 150
ID
Title
Description
OG000
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG001
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG002
Stage II: Group 7 SP0202-VII
Secondary
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4
The GMs for serotype specific OPA titers were measured using MOPA which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.
Results are based on PPAS3-OPA subset which is a subset of the FAS3 for infants. Only participants with data collected for each specified category are reported.
Posted
Geometric Mean
95% Confidence Interval
1/dil
Day 330
ID
Title
Description
OG000
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG001
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG002
Stage II: Group 7 SP0202-VII
Secondary
For Infants: GMC of Anti-Rotavirus Serum Immunoglobulin A (IgA) Antibodies 30 Days Post-Dose 3
Anti-rotavirus IgA antibodies in human serum were measured by enzyme linked immunosorbent assay (ELISA). A reference standard assayed on each plate was used to calculate the amount of specific anti-rotavirus IgA antibody in the units assigned by the reference standard.
Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for this outcome measure are reported.
Posted
Geometric Mean
95% Confidence Interval
Units (U)/mL
Day 150
ID
Title
Description
OG000
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG001
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG002
Secondary
For Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3
Percentage of participants with toxoid concentration >=0.10 mcg/mL for diphtheria and tetanus and >=0.15 mcg/mL for PRP are presented. Anti-diphtheria and anti-tetanus concentrations were measured using electro-chemiluminescence assay (ECL) and anti-PRP concentrations were measured using a Farr-type radioimmunoassay.
Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for each specified category are reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 150
ID
Title
Description
OG000
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG001
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Secondary
For Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3
Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Response was defined as a titer >=8.
Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for each specified category are reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 150
ID
Title
Description
OG000
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG001
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG002
Stage II: Group 7 SP0202-VII
Secondary
For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3
Serum samples were collected for analysis by ECL to determine the GMC of antibodies to the following Pertussis antigens: Pertussis toxoid/toxin, Filamentous hemagglutinin, Pertactin and Fimbriae types 2 and 3.
Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for this outcome measure are reported.
Posted
Geometric Mean
95% Confidence Interval
ELISA units (EU)/mL
Day 150
ID
Title
Description
OG000
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG001
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG002
Stage II: Group 7 SP0202-VII
Secondary
For Infants: Percentage of Participants With Antibody Responses to Hepatitis-B Antigens 30 Days Post-Dose 3
Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ immunodiagnostic system using chemiluminescence detection technology. The VITROS ECi immunodiagnostic system uses an antibody mediated antigen sandwich formation to detect the presence of anti-hepatitis B surface antigen total immunoglobulin in human serum. The threshold presented is >=10 milli international units (mIU).
Results are based on PPAS2 which is a subset of the FAS2 for infants. Only participants with data collected for this outcome measure are reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 150
ID
Title
Description
OG000
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG001
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Secondary
For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4
Anti-measles antibodies were determined by bulk measles IgG enzyme immunoassay (EIA); anti-mumps antibodies by ELISA, anti-rubella antibodies by bulk rubella IgG EIA and anti-varicella antibodies were determined by glycoprotein ELISA to detect total IgG antibody to respective virus before and after vaccination with a virus-containing vaccine. Percentage of participants with anti-measles antibody concentrations >=255 mIU/mL, anti-mumps antibody concentrations: >=10 antibody units/mL, anti-rubella antibody concentrations >=10 IU/mL and anti-varicella concentrations >=5 units/mL is reported in this outcome measure.
Results are based on PPAS3 which is a subset of the FAS3 for infants. Only participants with data collected for this outcome measure are reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 330
ID
Title
Description
OG000
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG001
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Time Frame
AEs data was collected from first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days. All-cause mortality was collected up to end of the study (Stage I: 6 months and Stage II: 19 months)
Description
Analysis was performed on the safety analysis set. One participant who was randomized to the reporting group "Stage II: Group 7 SP0202-VII" was administered SP0202-IIb formulation. Therefore, the participant was included in "Stage II: Group 5 SP0202-IIb" for analysis.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Stage I: Group 1 SP0202-IIb
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-IIb formulation, concomitantly administered with Pentacel.
0
35
0
35
28
35
EG001
Stage I: Group 2 SP0202-VI
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.
0
34
1
34
28
34
EG002
Stage I: Group 3 SP0202-VII
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.
0
35
0
35
29
35
EG003
Stage I: Group 4 Prevnar 13
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.
0
34
0
34
25
34
EG004
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
0
180
3
180
160
180
EG005
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
1
178
9
178
164
178
EG006
Stage II: Group 7 SP0202-VII
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
0
176
8
176
159
176
EG007
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
0
176
9
176
158
176
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Heart Disease Congenital
Congenital, familial and genetic disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG0030 events0 affected34 at risk
EG004
Eyelid Ptosis
Eye disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Death
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Bacterial Diarrhoea
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Bronchiolitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Covid-19
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Gastroenteritis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Hand-Foot-And-Mouth Disease
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Pneumonia
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Pneumonia Influenzal
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Pyelonephritis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Respiratory Syncytial Virus Bronchiolitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Respiratory Syncytial Virus Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Subcutaneous Abscess
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Viral Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Accidental Overdose
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Limb Asymmetry
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Febrile Convulsion
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Respiratory Distress
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0022 events2 affected35 at risk
EG0030 events0 affected34 at risk
EG00422 events18 affected180 at risk
EG00518 events16 affected178 at risk
EG00620 events17 affected176 at risk
EG00726 events25 affected176 at risk
Teething
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0003 events3 affected35 at risk
EG0010 events0 affected34 at risk
EG0022 events2 affected35 at risk
EG003
Crying
General disorders
MedDra 26.0
Systematic Assessment
EG00016 events16 affected35 at risk
EG0016 events6 affected34 at risk
EG00217 events17 affected35 at risk
EG003
Injection Site Bruising
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0011 events1 affected34 at risk
EG0022 events1 affected35 at risk
EG003
Injection Site Erythema
General disorders
MedDra 26.0
Systematic Assessment
EG00031 events20 affected35 at risk
EG00125 events14 affected34 at risk
EG00221 events13 affected35 at risk
EG003
Injection Site Pain
General disorders
MedDra 26.0
Systematic Assessment
EG00026 events16 affected35 at risk
EG00120 events12 affected34 at risk
EG00234 events19 affected35 at risk
EG003
Injection Site Swelling
General disorders
MedDra 26.0
Systematic Assessment
EG00024 events16 affected35 at risk
EG00121 events14 affected34 at risk
EG00222 events14 affected35 at risk
EG003
Pyrexia
General disorders
MedDra 26.0
Systematic Assessment
EG0004 events4 affected35 at risk
EG0017 events7 affected34 at risk
EG0028 events8 affected35 at risk
EG003
Bronchiolitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Otitis Media
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Otitis Media Acute
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0001 events1 affected35 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected35 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0009 events9 affected35 at risk
EG0017 events7 affected34 at risk
EG00213 events13 affected35 at risk
EG003
Somnolence
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG00012 events12 affected35 at risk
EG00111 events11 affected34 at risk
EG00212 events12 affected35 at risk
EG003
Irritability
Psychiatric disorders
MedDra 26.0
Systematic Assessment
EG00021 events21 affected35 at risk
EG00116 events16 affected34 at risk
EG00222 events22 affected35 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG007
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
34
OG004180
OG005178
OG006176
OG007176
0
OG0040
OG0050
OG0060
OG0070
OG002
Stage I: Group 3 SP0202-VII
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.
OG003
Stage I: Group 4 Prevnar 13
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.
OG004
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG005
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG006
Stage II: Group 7 SP0202-VII
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG007
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG00031
OG00132
OG00231
OG00330
OG004168
OG005170
OG006168
OG007171
Title
Denominators
Categories
Title
Measurements
OG00021
OG00118
OG00221
OG00313
OG004119
OG005128
OG006126
OG007124
Stage I: Group 3 SP0202-VII
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.
OG003
Stage I: Group 4 Prevnar 13
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.
OG004
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG005
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG006
Stage II: Group 7 SP0202-VII
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG007
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG00033
OG00133
OG00233
OG00330
OG004168
OG005169
OG006168
OG007171
Title
Denominators
Categories
Title
Measurements
OG00025
OG00123
OG00227
OG00324
OG004139
OG005143
OG006137
OG007138
Stage I: Group 3 SP0202-VII
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.
OG003
Stage I: Group 4 Prevnar 13
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.
OG004
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG005
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG006
Stage II: Group 7 SP0202-VII
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG007
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG00035
OG00134
OG00235
OG00334
OG004180
OG005178
OG006176
OG007176
Title
Denominators
Categories
Title
Measurements
OG0007
OG0013
OG0024
OG0036
OG004122
OG005116
OG006118
OG007117
Stage I: Group 2 SP0202-VI
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VI formulation, concomitantly administered with Pentacel.
OG002
Stage I: Group 3 SP0202-VII
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.
OG003
Stage I: Group 4 Prevnar 13
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.
OG004
Stage II: Group 5 SP0202-IIb
Infants aged 2 months received 3 doses of SP0202-IIb formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG005
Stage II: Group 6 SP0202-VI
Infants aged 2 months were received 3 doses of SP0202-VI formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG006
Stage II: Group 7 SP0202-VII
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG007
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG00035
OG00134
OG00235
OG00334
OG004180
OG005178
OG006176
OG007176
Title
Denominators
Categories
Any SAEs
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0043
OG0059
OG0068
OG0079
Any AESIs
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG002
Stage I: Group 3 SP0202-VII
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received 1 dose of SP0202-VII formulation, concomitantly administered with Pentacel.
OG003
Stage I: Group 4 Prevnar 13
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.
Units
Counts
Participants
OG00025
OG00126
OG00227
OG00329
Title
Denominators
Categories
Serotype 1
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Title
Measurements
OG0002.46(1.59 to 3.82)
OG0012.12(1.40 to 3.21)
OG0023.29(2.55 to 4.24)
OG003
Serotype 3
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00328
Serotype 4
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 5
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 6A
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 6B
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 7F
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 9V
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00328
Serotype 14
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 18C
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 19A
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 19F
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 23F
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 8
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 9N
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 10A
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00327
Serotype 11A
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 12F
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00227
ParticipantsOG00328
Serotype 15B
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 22F
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00329
Serotype 33F
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00227
ParticipantsOG00327
OG002
Stage II: Group 7 SP0202-VII
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG003
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG000133
OG001122
OG002125
OG003132
Title
Denominators
Categories
Serotype 1
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Title
Measurements
OG00097.7(93.5 to 99.5)
OG00196.7(91.8 to 99.1)
OG00295.2(89.8 to 98.2)
OG003
Serotype 3
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 4
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 5
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 6A
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 6B
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 7F
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 9V
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 14
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003131
Serotype 18C
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 19A
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 19F
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003131
Serotype 23F
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 8
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003131
Serotype 9N
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 10A
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002120
ParticipantsOG003132
Serotype 11A
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 12F
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 15B
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003131
Serotype 22F
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 33F
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003131
OG002
Stage II: Group 7 SP0202-VII
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG003
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG000133
OG001122
OG002125
OG003132
Title
Denominators
Categories
Serotype 1
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Title
Measurements
OG0001.91(1.66 to 2.19)
OG0012.21(1.88 to 2.61)
OG0021.97(1.66 to 2.34)
OG003
Serotype 3
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 4
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 5
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 6A
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 6B
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 7F
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 9V
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 14
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003131
Serotype 18C
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 19A
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 19F
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003131
Serotype 23F
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 8
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003131
Serotype 9N
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 10A
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 11A
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 12F
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 15B
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003131
Serotype 22F
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003132
Serotype 33F
ParticipantsOG000133
ParticipantsOG001122
ParticipantsOG002125
ParticipantsOG003131
OG002
Stage II: Group 7 SP0202-VII
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG003
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG000122
OG001108
OG002101
OG003128
Title
Denominators
Categories
Serotype 1
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
Title
Measurements
OG0003.16(2.68 to 3.73)
OG0013.59(3.02 to 4.26)
OG0023.44(2.87 to 4.12)
OG003
Serotype 3
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003127
Serotype 4
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
Serotype 5
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
Serotype 6A
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
Serotype 6B
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002100
ParticipantsOG003128
Serotype 7F
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
Serotype 9V
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
Serotype 14
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
Serotype 18C
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
Serotype 19A
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
Serotype 19F
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002100
ParticipantsOG003128
Serotype 23F
ParticipantsOG000122
ParticipantsOG001107
ParticipantsOG002101
ParticipantsOG003128
Serotype 8
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
Serotype 9N
ParticipantsOG000121
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
Serotype 10A
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
Serotype 11A
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
Serotype 12F
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
Serotype 15B
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003126
Serotype 22F
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002100
ParticipantsOG003128
Serotype 33F
ParticipantsOG000122
ParticipantsOG001108
ParticipantsOG002101
ParticipantsOG003128
OG003
Stage I: Group 4 Prevnar 13
Toddlers aged between 12 and 15 months who previously received the 3-dose primary series of Prevnar 13 received another dose of Prevnar 13, concomitantly administered with Pentacel.
Units
Counts
Participants
OG00024
OG00124
OG00223
OG00325
Title
Denominators
Categories
Serotype 1
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00325
Title
Measurements
OG000138(62.1 to 306)
OG00194.2(49.9 to 178)
OG002177(92.3 to 339)
OG003
Serotype 3
ParticipantsOG00024
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00325
Serotype 4
ParticipantsOG00024
ParticipantsOG00123
ParticipantsOG00223
ParticipantsOG00325
Serotype 5
ParticipantsOG00024
ParticipantsOG00123
ParticipantsOG00222
ParticipantsOG00325
Serotype 6A
ParticipantsOG00024
ParticipantsOG00121
ParticipantsOG00222
ParticipantsOG00325
Serotype 6B
ParticipantsOG00024
ParticipantsOG00123
ParticipantsOG00223
ParticipantsOG00325
Serotype 7F
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00325
Serotype 9V
ParticipantsOG00024
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00324
Serotype 14
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00325
Serotype 18C
ParticipantsOG00024
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00325
Serotype 19A
ParticipantsOG00024
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00324
Serotype 19F
ParticipantsOG00024
ParticipantsOG00123
ParticipantsOG00222
ParticipantsOG00325
Serotype 23F
ParticipantsOG00024
ParticipantsOG00123
ParticipantsOG00222
ParticipantsOG00325
Serotype 8
ParticipantsOG00024
ParticipantsOG00123
ParticipantsOG00223
ParticipantsOG00325
Serotype 9N
ParticipantsOG00024
ParticipantsOG00123
ParticipantsOG00223
ParticipantsOG00325
Serotype 10A
ParticipantsOG00024
ParticipantsOG00123
ParticipantsOG00223
ParticipantsOG00324
Serotype 11A
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Serotype 12F
ParticipantsOG00024
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00325
Serotype 15B
ParticipantsOG00021
ParticipantsOG00119
ParticipantsOG00221
ParticipantsOG00324
Serotype 22F
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00325
Serotype 33F
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00325
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG003
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG00089
OG00185
OG00283
OG00395
Title
Denominators
Categories
Serotype 1
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00395
Title
Measurements
OG00073.6(53.4 to 101)
OG00181.7(59.1 to 113)
OG00266.4(46.7 to 94.5)
OG003
Serotype 3
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00282
ParticipantsOG00393
Serotype 4
ParticipantsOG00087
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00395
Serotype 5
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00395
Serotype 6A
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00395
Serotype 6B
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00395
Serotype 7F
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00395
Serotype 9V
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00281
ParticipantsOG00395
Serotype 14
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00395
Serotype 18C
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00395
Serotype 19A
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00395
Serotype 19F
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00395
Serotype 23F
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00393
Serotype 8
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00395
Serotype 9N
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00394
Serotype 10A
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00394
Serotype 11A
ParticipantsOG00088
ParticipantsOG00185
ParticipantsOG00281
ParticipantsOG00394
Serotype 12F
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00394
Serotype 15B
ParticipantsOG00086
ParticipantsOG00185
ParticipantsOG00281
ParticipantsOG00393
Serotype 22F
ParticipantsOG00089
ParticipantsOG00185
ParticipantsOG00283
ParticipantsOG00395
Serotype 33F
ParticipantsOG00089
ParticipantsOG00183
ParticipantsOG00283
ParticipantsOG00390
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG003
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG00082
OG00173
OG00270
OG00392
Title
Denominators
Categories
Serotype 1
ParticipantsOG00082
ParticipantsOG00173
ParticipantsOG00269
ParticipantsOG00392
Title
Measurements
OG000407(295 to 561)
OG001355(255 to 495)
OG002320(211 to 486)
OG003
Serotype 3
ParticipantsOG00082
ParticipantsOG00170
ParticipantsOG00269
ParticipantsOG00387
Serotype 4
ParticipantsOG00081
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00385
Serotype 5
ParticipantsOG00082
ParticipantsOG00172
ParticipantsOG00268
ParticipantsOG00392
Serotype 6A
ParticipantsOG00082
ParticipantsOG00172
ParticipantsOG00269
ParticipantsOG00390
Serotype 6B
ParticipantsOG00081
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00391
Serotype 7F
ParticipantsOG00082
ParticipantsOG00172
ParticipantsOG00269
ParticipantsOG00390
Serotype 9V
ParticipantsOG00080
ParticipantsOG00171
ParticipantsOG00269
ParticipantsOG00386
Serotype 14
ParticipantsOG00082
ParticipantsOG00173
ParticipantsOG00270
ParticipantsOG00392
Serotype 18C
ParticipantsOG00082
ParticipantsOG00172
ParticipantsOG00268
ParticipantsOG00392
Serotype 19A
ParticipantsOG00080
ParticipantsOG00170
ParticipantsOG00267
ParticipantsOG00382
Serotype 19F
ParticipantsOG00081
ParticipantsOG00171
ParticipantsOG00269
ParticipantsOG00388
Serotype 23F
ParticipantsOG00080
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00387
Serotype 8
ParticipantsOG00082
ParticipantsOG00173
ParticipantsOG00270
ParticipantsOG00392
Serotype 9N
ParticipantsOG00081
ParticipantsOG00171
ParticipantsOG00270
ParticipantsOG00390
Serotype 10A
ParticipantsOG00082
ParticipantsOG00173
ParticipantsOG00270
ParticipantsOG00381
Serotype 11A
ParticipantsOG00082
ParticipantsOG00173
ParticipantsOG00266
ParticipantsOG00385
Serotype 12F
ParticipantsOG00081
ParticipantsOG00169
ParticipantsOG00269
ParticipantsOG00375
Serotype 15B
ParticipantsOG00078
ParticipantsOG00172
ParticipantsOG00267
ParticipantsOG00382
Serotype 22F
ParticipantsOG00079
ParticipantsOG00171
ParticipantsOG00263
ParticipantsOG00380
Serotype 33F
ParticipantsOG00081
ParticipantsOG00170
ParticipantsOG00266
ParticipantsOG00390
Stage II: Group 7 SP0202-VII
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG003
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG000119
OG001105
OG002110
OG003120
Title
Denominators
Categories
Title
Measurements
OG000407(303 to 545)
OG001390(283 to 537)
OG002494(369 to 661)
OG003393(277 to 560)
OG002
Stage II: Group 7 SP0202-VII
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG003
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG000130
OG001118
OG002123
OG003130
Title
Denominators
Categories
Anti-Diphtheria toxoid
ParticipantsOG000130
ParticipantsOG001118
ParticipantsOG002123
ParticipantsOG003130
Title
Measurements
OG00094.6(89.2 to 97.8)
OG00197.5(92.7 to 99.5)
OG00295.9(90.8 to 98.7)
OG003
Anti-Tetanus toxoid
ParticipantsOG000130
ParticipantsOG001118
ParticipantsOG002123
ParticipantsOG003130
Anti-PRP
ParticipantsOG000127
ParticipantsOG001113
ParticipantsOG002112
ParticipantsOG003128
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG003
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG000125
OG001109
OG002114
OG003127
Title
Denominators
Categories
Anti-poliovirus 1
ParticipantsOG000123
ParticipantsOG001109
ParticipantsOG002114
ParticipantsOG003126
Title
Measurements
OG00099.2(95.6 to 100)
OG001100(96.7 to 100)
OG00297.4(92.5 to 99.5)
OG003
Anti-poliovirus 2
ParticipantsOG000122
ParticipantsOG001105
ParticipantsOG002112
ParticipantsOG003124
Anti-poliovirus 3
ParticipantsOG000125
ParticipantsOG001109
ParticipantsOG002111
ParticipantsOG003127
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG003
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG000130
OG001118
OG002123
OG003130
Title
Denominators
Categories
Pertussis toxoid/toxin
Title
Measurements
OG00067.9(60.1 to 76.6)
OG00177.2(67.4 to 88.5)
OG00266.3(57.4 to 76.6)
OG00368.3(59.7 to 78.2)
Filamentous hemagglutinin
Title
Measurements
OG000109(94.9 to 124)
OG001107(94.4 to 122)
OG002108(95.2 to 123)
OG003
Pertactin
Title
Measurements
OG00038.3(32.3 to 45.4)
OG00136.1(29.4 to 44.3)
OG00239.8(32.8 to 48.3)
OG003
Fimbriae types 2 and 3
Title
Measurements
OG000347(295 to 408)
OG001341(286 to 407)
OG002315(262 to 380)
OG003
OG002
Stage II: Group 7 SP0202-VII
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG003
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
Units
Counts
Participants
OG000121
OG001106
OG002108
OG003123
Title
Denominators
Categories
Title
Measurements
OG00098.3(94.2 to 99.8)
OG00199.1(94.9 to 100)
OG00298.1(93.5 to 99.8)
OG00399.2(95.6 to 100)
OG002
Stage II: Group 7 SP0202-VII
Infants aged 2 months were received 3 doses of SP0202-VII formulation at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).
OG003
Stage II: Group 8 Prevnar 13
Infants aged 2 months were received 3 doses of Prevnar 13 at 2, 4, and 6 months of age and fourth dose at 12 to 15 months of age, co-administered with pediatric vaccines recommended at this age (that is, Pentacel, RotaTeq and Engerix-B at 2, 4 and 6 months of age and M-M-RII and Varivax at 12 to 15 months of age).