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

Vaccines, Pneumococcal Clinical Trial

Official title:

A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368966
• Other study ID #: 6096A1-501
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2006
• Last updated: July 6, 2012
• Start date: October 2006
• Est. completion date: July 2008

Study information

• Verified date: July 2012
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 vaccinations in Spain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 619
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 98 Days

Eligibility

Inclusion Criteria:

• Healthy 2-month-old infants

• Available for the entire study period

Exclusion criteria:

• Previous vaccination with any vaccine before the start of the study

• Known contraindication to vaccination

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vaccines, Pneumococcal

Intervention

Biological:
• 13-valent Pneumococcal Conjugate Vaccine

• 7-valent Pneumococcal Conjugate Vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of = 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series	Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (=) 1:8 for meningococcal C SBA titer and = 0.10 or >=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.	One month after 2-doses of the infant series (5 months of age)	No
Primary	Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series		One month after 2-doses of the infant series (5 months of age)	No
Primary	Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series		One month after 2-doses of the infant series (5 months of age)	No
Primary	Percentage of Participants Reporting Pre-Specified Local Reactions	Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (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 (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.	During the 4-day period after each dose	Yes
Primary	Percentage of Participants Reporting Pre-Specified Systemic Events	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.	During the 4-day period after each dose	Yes
Primary	Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose	GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (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.	One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)	No
Primary	Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose	Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.	One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)	No
Primary	Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose		One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)	No
Primary	Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose		One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)	No
Primary	Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose	GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.	One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)	No
Primary	Percentage of Participants Achieving Antibody Level = 0.35 Microgram Per Milliliter (µg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose	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, present in both 13vPnC and 7vPnC (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.	One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)	No