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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004221-25 | EudraCT Number | ||
| PRI02C | Other Identifier | MCMVaccBV Protocol ID | |
| V419-010 | Other Identifier | Merck Protocol Number |
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| Name | Class |
|---|---|
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
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To evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age
Primary objectives
Secondary objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Experimental | [Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PR5I | Biological | Hexavalent PR5I vaccine (DTaP-HB-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed [DTaP], Hepatitis B [HB; Recombinant DNA], Inactivated Poliovirus [IPV], and Haemophilus influenzae type b [Hib] conjugate vaccine [adsorbed]) at 0.5 mL for IM injection (left upper thigh) at 2 and 6 months of age. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL | The percentage of participants with an anti-HBsAg antibody titer ≥10 mill-International Units/mL (mIU/mL) was assessed. Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the concentration of antibodies to HBsAg. | Month 5 (one month after receiving Vaccination 3) |
| Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL | The percentage of participants with an anti-Polyribosylribitol Phosphate (PRP) antibody titer ≥0.15 µg/mL was assessed. Participant serum samples were collected for analysis by radioimmunoassay to determine the concentration of antibodies to PRP, a Haemophilus influenzae type b (Hib) capsular polysaccharide. | Month 5 (one month after receiving Vaccination 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg) | Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the geometric mean concentration of antibodies to Hepatitis B Surface Antigen (HBsAg). The unit of measure is milli International Units/mL (mIU/mL). | Month 5 (one month after receiving Vaccination 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28583305 | Derived | Martinon-Torres F, Boisnard F, Thomas S, Sadorge C, Borrow R; PRI02C study group. Immunogenicity and safety of a new hexavalent vaccine (DTaP5-IPV-HB-Hib) administered in a mixed primary series schedule with a pentavalent vaccine (DTaP5-IPV-Hib). Vaccine. 2017 Jun 27;35(30):3764-3772. doi: 10.1016/j.vaccine.2017.05.043. Epub 2017 Jun 2. |
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Participants progressed through the study as a single group, with all participants receiving the same mixed-schedule vaccination series. Vaccination (V1) was administered on Study Day 0 (2 months of age), with V2 (4 months of age) and V3 (6 months of age) administered at Study Months 2 and 4, respectively.
The study enrolled N=385 infant participants previously vaccinated with only 1 dose of monovalent Hepatitis B vaccine, within 3 days after birth, outside of study context.
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| ID | Title | Description |
|---|---|---|
| FG000 | PR5I (V1); Pediacel® (V2); PR5I (V3) | [Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants receiving ≥1 dose of study vaccination.
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| ID | Title | Description |
|---|---|---|
| BG000 | PR5I (V1); Pediacel® (V2); PR5I (V3) | [Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL | The percentage of participants with an anti-HBsAg antibody titer ≥10 mill-International Units/mL (mIU/mL) was assessed. Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the concentration of antibodies to HBsAg. | All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 5 (one month after receiving Vaccination 3) |
|
Up to ~6 months (Serious adverse events and deaths were collected for the duration of the study. Solicited ISRs / AEs were collected up to 5 days following each vaccination; unsolicited ISRs / AEs were collected up to 15 days following each vaccination.)
Analysis population includes all participants receiving ≥1 dose of study vaccination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PR5I (V1); Pediacel® (V2); PR5I (V3) | [Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000617220 | Vaxelis |
| C541234 | diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine |
| C492535 | RotaTeq |
| C538862 | 13-valent pneumococcal vaccine |
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|
| Pediacel® | Biological | Pentavalent Pediacel® vaccine (DTaP-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed [DTaP], Inactivated Poliovirus [IPV], and Haemophilus influenzae type b [Hib] conjugate vaccine [adsorbed]) at 0.5 mL for IM injection (left upper thigh) at 4 months of age. |
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| NeisVac-C® | Biological | Meningococcal group C (MCC) polysaccharide conjugate vaccine (adsorbed) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age. |
|
| RotaTeq® | Biological | Human-bovine rotavirus reassortants (live) vaccine 2 mL oral administration at 2, 4 and 6 months of age. RotaTeq® administered prior to any other vaccine administration to avoid having the infant participants spit up the RotaTeq® when crying. |
|
| Prevenar 13® | Biological | Pneumococcal polysaccharide conjugate vaccine [PCV; 13-valent, adsorbed]) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age. |
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| Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen | Participant serum samples were collected for analysis by radioimmunoassay (RIA) to determine the geometric mean concentration of antibodies to polyribosylribitol phosphate (PRP), a Haemophilus influenzae type b (Hib) capsular polysaccharide. | Month 5 (one month after receiving Vaccination 3) |
| Geometric Mean Concentration of Antibodies to Diphtheria Toxin | Participant serum samples were collected for analysis with a Micrometabolic Inhibition Test (MIT) to determine the geometric mean concentration of neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL). | Month 5 (one month after receiving Vaccination 3) |
| Geometric Mean Concentration of Antibodies to Tetanus Toxin | Participant serum samples were collected for analysis by Enzyme-linked Immunosorbent Assay (ELISA) to determine the geometric mean concentration of antibodies to tetanus toxin. The unit of measure is International Units/mL (IU/mL). | Month 5 (one month after receiving Vaccination 3) |
| Geometric Mean Concentrations of Antibodies to Pertussis Antigens | Participant serum samples were collected for analysis by ELISA to determine the geometric mean concentration of antibodies (Abs) to the following Pertussis antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN) and fimbriae types (FIM) 2&3. The unit of measure is ELISA Units/mL (EU/mL). | Month 5 (one month after receiving Vaccination 3) |
| Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3) | Participant serum samples were collected for analysis with a Micrometabolic Inhibition Test (MIT) to determine the geometric mean titer of neutralizing antibodies (Abs) to Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3). The unit of measure is titer, expressed as the reciprocal dilution of the highest dilution that neutralizes 50% of the challenge virus. | Month 5 (one month after receiving Vaccination 3) |
| Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3) | Participants were considered as responding if the observed concentration or titer for antibodies (Abs) to specific antigens exceeded the following thresholds:
The percentage of participants considered as responding to the individual antigen (per the response threshold[s]) were assessed. | Month 5 (one month after receiving Vaccination 3) |
| Geometric Mean Titer of Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibodies | Participant serum samples were collected to determine the geometric mean titer of anti-MCC antibodies, measured by the Serum Bactericidal Antibody assay using rabbit complement (rSBA). The unit of measure is titer, expressed as the reciprocal of the final serum dilution giving ≥50% killing of the challenge bacterial strain. | Month 3 (one month after receiving Vaccination 2) |
| Percentage of Participants With an Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibody Titer ≥8 | The percentage of participants with an anti-MCC antibody titer ≥8 was assessed. Participant serum samples were collected and analyzed for anti-MCC antibodies with the Serum Bactericidal Antibody assay using rabbit complement (rSBA). | Month 3 (one month after receiving Vaccination 2) |
| Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination | The percentage of participants with a body temperature ≥38.0°C from Day 1 to Day 5 after each vaccination was assessed. Per protocol, the participant's parent(s)/legal representative recorded daily body temperature measurements each evening by the axillary route (N=3 collected via rectal route; N=1 collected via oral route) and recorded these observations on the Vaccine Report Card (VRC). Temperatures were based on actual temperatures recorded with no adjustments for the route of assessment. | Up to Day 5 following each vaccination |
| Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | The number of participants experiencing solicited ISRs related to the PRI5 or Pediacel® vaccination was assessed. Solicited ISRs (erythema, pain and swelling) occurring at the PR5I or Pediacel® injection site were always considered related to the PR5I or Pediacel® vaccine, respectively. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing solicited ISRs up to Day 5 after each vaccination and after any vaccination. | Up to Day 5 following each vaccination |
| Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | The number of participants experiencing solicited ISRs related to the NeisVac-C® (MCC) vaccination was assessed. Solicited ISRs (erythema, pain and swelling) occurring at the NeisVac-C® (MCC) injection site were always considered related to the NeisVac-C® (MCC) vaccine. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing solicited ISRs up to Day 5 after each NeisVac-C® vaccination and after any NeisVac-C® vaccination. | Up to Day 5 following each vaccination |
| Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | The number of participants experiencing unsolicited ISRs related to the PRI5 or Pediacel® vaccination was assessed. Unsolicited ISRs occurring at the PR5I or Pediacel® injection site were always considered related to the PR5I or Pediacel® vaccine, respectively. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing unsolicited ISRs up to Day 15 after each vaccination and after any vaccination. | Up to Day 15 following each vaccination |
| Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | The number of participants experiencing unsolicited ISRs related to the NeisVac-C® (MCC) vaccination was assessed. Unsolicited ISRs occurring at the NeisVac-C® (MCC) injection site were always considered related to the NeisVac-C® (MCC) vaccine. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing unsolicited ISRs up to Day 15 after each NeisVac-C® vaccination and after any NeisVac-C® vaccination. | Up to Day 15 following each vaccination |
| Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | The number of participants experiencing solicited systemic AEs (crying, decreased appetite, irritability, somnolence, pyrexia, and vomiting) was assessed. Each day from Day 1 to Day 5 following each vaccination, the participant's parent(s)/legal representative recorded all solicited AEs on the VRC. Data are presented for the number of participants experiencing solicited AEs up to Day 5 after each vaccination and after any vaccination. | Up to Day 5 following each vaccination |
| Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE) | The number of participants experiencing unsolicited systemic AEs was assessed. Data are presented for the number of participants experiencing unsolicited AEs up to Day 15 after each vaccination and after any vaccination. | Up to Day 15 following each vaccination |
| Number of Participants Experiencing a Serious Adverse Event (SAE) | An SAE is an adverse event (AE) that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially require medical or surgical intervention. | Up to ~6 months (at any time during the study) |
| Days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Body Weight | Includes all participants receiving ≥1 dose of study vaccination, having available data for body weight. | Mean | Standard Deviation | kg |
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| Primary | Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL | The percentage of participants with an anti-Polyribosylribitol Phosphate (PRP) antibody titer ≥0.15 µg/mL was assessed. Participant serum samples were collected for analysis by radioimmunoassay to determine the concentration of antibodies to PRP, a Haemophilus influenzae type b (Hib) capsular polysaccharide. | All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 5 (one month after receiving Vaccination 3) |
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| Secondary | Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg) | Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the geometric mean concentration of antibodies to Hepatitis B Surface Antigen (HBsAg). The unit of measure is milli International Units/mL (mIU/mL). | All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Month 5 (one month after receiving Vaccination 3) |
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| Secondary | Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen | Participant serum samples were collected for analysis by radioimmunoassay (RIA) to determine the geometric mean concentration of antibodies to polyribosylribitol phosphate (PRP), a Haemophilus influenzae type b (Hib) capsular polysaccharide. | All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Month 5 (one month after receiving Vaccination 3) |
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| Secondary | Geometric Mean Concentration of Antibodies to Diphtheria Toxin | Participant serum samples were collected for analysis with a Micrometabolic Inhibition Test (MIT) to determine the geometric mean concentration of neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL). | All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Month 5 (one month after receiving Vaccination 3) |
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| Secondary | Geometric Mean Concentration of Antibodies to Tetanus Toxin | Participant serum samples were collected for analysis by Enzyme-linked Immunosorbent Assay (ELISA) to determine the geometric mean concentration of antibodies to tetanus toxin. The unit of measure is International Units/mL (IU/mL). | All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Month 5 (one month after receiving Vaccination 3) |
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| Secondary | Geometric Mean Concentrations of Antibodies to Pertussis Antigens | Participant serum samples were collected for analysis by ELISA to determine the geometric mean concentration of antibodies (Abs) to the following Pertussis antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN) and fimbriae types (FIM) 2&3. The unit of measure is ELISA Units/mL (EU/mL). | All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Month 5 (one month after receiving Vaccination 3) |
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| Secondary | Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3) | Participant serum samples were collected for analysis with a Micrometabolic Inhibition Test (MIT) to determine the geometric mean titer of neutralizing antibodies (Abs) to Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3). The unit of measure is titer, expressed as the reciprocal dilution of the highest dilution that neutralizes 50% of the challenge virus. | All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Month 5 (one month after receiving Vaccination 3) |
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| Secondary | Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3) | Participants were considered as responding if the observed concentration or titer for antibodies (Abs) to specific antigens exceeded the following thresholds:
The percentage of participants considered as responding to the individual antigen (per the response threshold[s]) were assessed. | All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 5 (one month after receiving Vaccination 3) |
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| Secondary | Geometric Mean Titer of Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibodies | Participant serum samples were collected to determine the geometric mean titer of anti-MCC antibodies, measured by the Serum Bactericidal Antibody assay using rabbit complement (rSBA). The unit of measure is titer, expressed as the reciprocal of the final serum dilution giving ≥50% killing of the challenge bacterial strain. | All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Month 3 (one month after receiving Vaccination 2) |
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| Secondary | Percentage of Participants With an Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibody Titer ≥8 | The percentage of participants with an anti-MCC antibody titer ≥8 was assessed. Participant serum samples were collected and analyzed for anti-MCC antibodies with the Serum Bactericidal Antibody assay using rabbit complement (rSBA). | All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 3 (one month after receiving Vaccination 2) |
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| Secondary | Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination | The percentage of participants with a body temperature ≥38.0°C from Day 1 to Day 5 after each vaccination was assessed. Per protocol, the participant's parent(s)/legal representative recorded daily body temperature measurements each evening by the axillary route (N=3 collected via rectal route; N=1 collected via oral route) and recorded these observations on the Vaccine Report Card (VRC). Temperatures were based on actual temperatures recorded with no adjustments for the route of assessment. | All participants receiving ≥1 dose of any vaccination with corresponding safety follow-up data, having available body temperature data. | Posted | Number | Percentage of Participants | Up to Day 5 following each vaccination |
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| Secondary | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | The number of participants experiencing solicited ISRs related to the PRI5 or Pediacel® vaccination was assessed. Solicited ISRs (erythema, pain and swelling) occurring at the PR5I or Pediacel® injection site were always considered related to the PR5I or Pediacel® vaccine, respectively. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing solicited ISRs up to Day 5 after each vaccination and after any vaccination. | All participants receiving ≥1 dose of PR5I/Pediacel® vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm) with PR5I/Pediacel®. | Posted | Count of Participants | Participants | Up to Day 5 following each vaccination |
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| Secondary | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | The number of participants experiencing solicited ISRs related to the NeisVac-C® (MCC) vaccination was assessed. Solicited ISRs (erythema, pain and swelling) occurring at the NeisVac-C® (MCC) injection site were always considered related to the NeisVac-C® (MCC) vaccine. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing solicited ISRs up to Day 5 after each NeisVac-C® vaccination and after any NeisVac-C® vaccination. | All participants receiving ≥1 dose of NeisVac-C® vaccination with corresponding safety follow-up data after each vaccination (for V1 and V2 arms) and after any vaccination (for V1; V2 arm) with NeisVac-C®. | Posted | Count of Participants | Participants | Up to Day 5 following each vaccination |
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| Secondary | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | The number of participants experiencing unsolicited ISRs related to the PRI5 or Pediacel® vaccination was assessed. Unsolicited ISRs occurring at the PR5I or Pediacel® injection site were always considered related to the PR5I or Pediacel® vaccine, respectively. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing unsolicited ISRs up to Day 15 after each vaccination and after any vaccination. | All participants receiving ≥1 dose of PR5I/Pediacel® vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm) with PR5I/Pediacel®. | Posted | Count of Participants | Participants | Up to Day 15 following each vaccination |
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| Secondary | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | The number of participants experiencing unsolicited ISRs related to the NeisVac-C® (MCC) vaccination was assessed. Unsolicited ISRs occurring at the NeisVac-C® (MCC) injection site were always considered related to the NeisVac-C® (MCC) vaccine. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing unsolicited ISRs up to Day 15 after each NeisVac-C® vaccination and after any NeisVac-C® vaccination. | All participants receiving ≥1 dose of NeisVac-C® vaccination with corresponding safety follow-up data after each vaccination (for V1 and V2 arms) and after any vaccination (for V1; V2 arm) with NeisVac-C®. | Posted | Count of Participants | Participants | Up to Day 15 following each vaccination |
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| Secondary | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | The number of participants experiencing solicited systemic AEs (crying, decreased appetite, irritability, somnolence, pyrexia, and vomiting) was assessed. Each day from Day 1 to Day 5 following each vaccination, the participant's parent(s)/legal representative recorded all solicited AEs on the VRC. Data are presented for the number of participants experiencing solicited AEs up to Day 5 after each vaccination and after any vaccination. | All participants receiving ≥1 dose of any vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm). | Posted | Count of Participants | Participants | Up to Day 5 following each vaccination |
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| Secondary | Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE) | The number of participants experiencing unsolicited systemic AEs was assessed. Data are presented for the number of participants experiencing unsolicited AEs up to Day 15 after each vaccination and after any vaccination. | All participants receiving ≥1 dose of any vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm). | Posted | Count of Participants | Participants | Up to Day 15 following each vaccination |
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|
|
| Secondary | Number of Participants Experiencing a Serious Adverse Event (SAE) | An SAE is an adverse event (AE) that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially require medical or surgical intervention. | All participants receiving ≥1 dose of study vaccination. | Posted | Count of Participants | Participants | Up to ~6 months (at any time during the study) |
|
|
|
| 0 |
| 385 |
| 12 |
| 385 |
| 360 |
| 385 |
| Periorbital cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Crying | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
Subsequent to public disclosure of study results, an investigator and colleagues participating in a multicenter study may publish data collected in their center independently. In such case the Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations based on these study results 60 calendar days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential will be deleted prior to submission.
| Title | Measurements |
|---|---|
|
| Anti-FIM 2&3 Abs |
|
| Title | Measurements |
|---|---|
|
|
| Anti-Diptheria Ab ≥0.10 IU/mL |
|
|
| Anti-Tetanus ≥0.01 IU/mL |
|
|
| Anti-Tetanus Ab ≥0.10 IU/mL |
|
|
| Anti-IPV1 Ab Titer ≥8 |
|
|
| Anti-IPV2 Ab Titer ≥8 |
|
|
| Anti-IPV3 Ab Titer ≥8 |
|
|
| Injection-site pain |
|
| Injection-site swelling |
|
|
| Injection-site swelling |
|
| Injection-site discomfort |
|
| Injection-site haematoma |
|
| Injection-site haemorrhage |
|
| Injection-site induration |
|
| Injection-site warmth |
|
|
| Injection-site induration |
|
| Decreased appetite |
|
| Irritability |
|
| Pyrexia |
|
| Somnolence |
|
| Vomiting |
|