Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Phase 3

Completed

• Conditions: Vaccines, Pneumococcal
• Interventions: Biological: 13-valent pneumococcal conjugate vaccine; Biological: 7-valent pneumococcal conjugate vaccine; Drug: Pentavac

• Registration Number: NCT00366678
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-18
• Study First Posted: 2006-08-21
• Study Start: 2006-10
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Disposition First Submitted: 2009-02-26
• Disposition First Submitted QC: 2009-07-31
• Disposition First Posted: 2009-10-01
• Results First Submitted: 2010-03-26
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-06
• Last Update Submitted: 2012-07-06
• Results First Posted: 2012-08-15
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 613

Inclusion Criteria

• Healthy 2-month-old infants.
• Available for the entire study period.

Exclusion criteria:

· Known contraindication to vaccines.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
13-valent pneumococcal conjugate vaccine	13-valent pneumococcal conjugate vaccine	13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine	Pentavac	13-valent pneumococcal conjugate vaccine
7-valent pneumococcal conjugate vaccine	7-valent pneumococcal conjugate vaccine	7-valent pneumococcal conjugate vaccine
7-valent pneumococcal conjugate vaccine	Pentavac	7-valent pneumococcal conjugate vaccine

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group	One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)	Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group	One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group	One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group	One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group	One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC	One month after the 3-Dose Infant Series (at 5 months of age)	Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Percentage of Participants Reporting Pre-Specified Local Reactions	During the 4-day period after each dose	Local reactions were collected using an electronic diary. Tenderness (Tender)was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (Sev) (\>7.0 cm). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events	During the 4-day period after each dose	Systemic events (fever \[fv\] ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased \[decr\] appetite, irritability, increased \[incr\] sleep, decreased sleep, hives, use of medication \[med\] to treat symptoms \[sx\], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC	One month after the 3-Dose Infant Series (at 5 months of age)	Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups	One month after the toddler dose (at 13 months of age)	Percentages of participants achieving World health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups	One month after the Toddler Dose (at 13 months of age)	Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups	One month after the toddler dose (at 13 months of age)	Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose	One month after the toddler dose (at 13 months of age)	GMT as measured by opsonophagocytic activity assay (OPA) for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.