A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine - Manufacturing scale study

Phase 1

• Conditions: Healthy infants

• Registration Number: EUCTR2006-006204-11-PL
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-12
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Aged 2 months (42 to 98 days) at time of enrollment.
• Available for entire study period and whose parent/legal guardian can be reached by telephone.
• Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
• Parent/legal guardian must be able to complete all relevant study procedures during study participation.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Previous vaccination with licensed or investigational pneumococcal, Haemophilus influenzae type b (Hib) conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
• Known or suspected immune deficiency or suppression.
• History of culture-proven invasive disease caused by S pneumoniae.
• Major known congenital malformation or serious chronic disorders.
• Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy.
• Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
• Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
• Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary Objective:<br>• To assess the pneumococcal immune responses induced by manufacturing scale 13vPnC relative to the immune responses induced by pilot scale 13vPnC when measured 1month after the infant series.<br> <br>;Secondary Objective: Safety Objective:<br>• To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).;Primary end point(s): The primary endpoint for each of the pneumococcal serotypes is the proportion of subjects achieving a serotype specific IgG antibody concentration = 0.35 µg/mL measured 1 month after the infant series. This choice of an endpoint is based upon a World Health Organization (WHO) guideline for the pneumococcal serotypes.