Study Evaluating the Impact of a 13-valent Pneumococcal C... | NCT00508742

ID	Type	Description	Link
B1851007

Study Evaluating the Impact of a 13-valent Pneumococcal C... | NCT00508742 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	13 valent pneumococcal conjugate vaccine	Biological: 13-valent Pneumococcal Conjugate Vaccine
2	Active Comparator	7 valent pneumococcal conjugate vaccine	Biological: 7 valent pneumococcal conjugate vaccine

Name	Type	Description	Arm Group Labels	Other Names
13-valent Pneumococcal Conjugate Vaccine	Biological	1 dose at 2, 4, 6 and 12 months of age	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age	A new acquisition was defined as the detection of a serotype (here 6A' [6A + 6C] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age.	Month 7 through Month 24

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age		Month 7, 12, 13, 18, 24

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Sites (7)		Beersheba	Beer-Sheva	84101	Israel
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31995183	Derived	Dagan R, Jiang Q, Juergens C, Trammel J, Gruber WC, Scott DA. Carrier-Induced Hyporesponsiveness to Pneumococcal Conjugate Vaccines: Unraveling the Influence of Serotypes, Timing, and Previous Vaccine Dose. Clin Infect Dis. 2021 Feb 1;72(3):448-454. doi: 10.1093/cid/ciaa083.
28087146	Derived	Dagan R, Juergens C, Trammel J, Patterson S, Greenberg D, Givon-Lavi N, Porat N, Gruber WC, Scott DA. PCV13-vaccinated children still carrying PCV13 additional serotypes show similar carriage density to a control group of PCV7-vaccinated children. Vaccine. 2017 Feb 7;35(6):945-950. doi: 10.1016/j.vaccine.2016.12.052. Epub 2017 Jan 11.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Arm/Group Information

ID	Title	Description
FG000	13vPnC	13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
FG001	7vPnC	7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Periods

Title

Milestones

Reasons Not Completed

Period 1: Infant Series

Type	Comment	Milestone Data
STARTED		FG000932 subjects FG001934 subjects
Vaccinated Dose 1 (at 2 Months of Age)		FG000930 subjects FG001933 subjects
Vaccinated Dose 2 (at 4 Months of Age)		FG000904 subjects FG001902 subjects
Vaccinated Dose 3 (at 6 Months of Age)		FG000898 subjects FG001892 subjects
COMPLETED		FG000890 subjects FG001889 subjects
NOT COMPLETED		FG00042 subjects FG00145 subjects

Type	Comment	Reasons
Adverse Event		FG0005 subjects FG0014 subjects
Protocol Violation		FG0001 subjects FG001

Period 2: After Infant Series

Type	Comment	Milestone Data
STARTED		FG000890 subjects FG001889 subjects
COMPLETED		FG000883 subjects FG001

Period 3: Toddler Dose

Type	Comment	Milestone Data
STARTED		FG000883 subjects FG001878 subjects
COMPLETED		FG000858 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	13vPnC	13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
BG001	7vPnC

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Mean

Outcome Measures Module

Outcome Measures

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 a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age

A new acquisition was defined as the detection of a serotype (here 6A' [6A + 6C] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age.

Evaluable culture population included all participants who adhered to protocol requirements; received the treatment to which they were randomized; had at least 1 nasopharyngeal swab for the proposed analysis and no major protocol violations.

Posted

Number

95% Confidence Interval

percentage of participants

Month 7 through Month 24

ID	Title	Description
OG000	13vPnC	13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Adverse Events Module

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	Infant Series 13vPnC	Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Pfizer ClinicalTrials.gov Call Center	Pfizer, Inc.	1-800-718-1021		ClinicalTrials.gov_Inquiries@pfizer.com

Condition Browse Module

ID	Term
D011008	Pneumococcal Infections

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Intervention Browse Module

ID	Term
D000069443	Heptavalent Pneumococcal Conjugate Vaccine

ID	Term
D022242	Pneumococcal Vaccines
D022541	Streptococcal Vaccines
D001428	Bacterial Vaccines
D014612	Vaccines

Type	Comment	Reasons
Adverse Event		FG0002 subjects FG0016 subjects
Lost to Follow-up		FG0001 subjects FG0011 subjects
Protocol Violation		FG0001 subjects FG0010 subjects
Parent/Legal Guardian Request		FG0000 subjects FG0013 subjects
Failed to Return		FG0001 subjects FG0010 subjects
Other		FG0002 subjects FG0011 subjects

Type	Comment	Reasons
Adverse Event		FG0001 subjects FG0010 subjects
Lost to Follow-up		FG0002 subjects FG0013 subjects
Parent/Legal Guardian Request		FG00017 subjects FG0018 subjects
Other		FG0005 subjects FG0014 subjects

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Rate Ratio	0.56			2-Sided	95	0.47	0.65				No	Superiority or Other

Secondary

Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age

Evaluable culture population; 'n' is number of participants with at least 1 determinate nasopharyngeal culture result for given serotype combination at specified time points for each arm group respectively.

Posted

Number

95% Confidence Interval

percentage of participants

Month 7, 12, 13, 18, 24

ID	Title	Description
OG000	13vPnC	13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
OG001	7vPnC	7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Units	Counts
Participants	OG000881 OG001873

Title

Denominators