A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) Administered to Infants

Active, not recruiting

Conditions: Pneumococcal disease
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2008-004766-40-Outside-EU/EEA

Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active

Sex: All

Target Recruitment: 168

Inclusion Criteria

1. Aged 2 months (42 to 98 days) at time of enrollment.
2. Available for entire study period and whose parent/legal guardian can be reached by telephone.
3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
4.Parent/legal guardian must be able to complete all required study procedures during study participation.
5.Previous vaccination with hepatitis B virus vaccine (HBV) at birth and approximately 1 month of age.
Are the trial subjects under 18? yes
Number of subjects for this age range: 168
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

1.Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, pertussis, polio, or Haemophilus influenzae type b vaccine (Hib) vaccines.
2.A previous anaphylactic reaction to any vaccine or vaccine-related component.
3.Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus, pertussis, polio, or Hib vaccines.
4.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5.Known or suspected immune deficiency or suppression.
6.History of culture-proven invasive disease caused by Streptococcus pneumoniae.
7.Major known congenital malformation or serious chronic disorders.
8.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.
9.Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; example, Synagis.
10.Participation in another investigational trial. Participation in purely observational studies is acceptable.
11. Infant who is a direct descendant (eg, child or grandchild) 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
Secondary Objective: To describe the pneumococcal immune responses induced by 13vPnC relative to the immune responses induced by 7vPnC when measured 1 month after the toddler dose.;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 Greater Than or Equal to (=) 0.35 microgram per milliliter (µg/mL) measured 1 month after the infant series.;Main Objective: To describe the pneumococcal immune responses induced by 13 valent pneumococcal conjugate vaccine (13vPnC) relative to the pneumococcal immune responses induced by 7 valent pneumococcal conjugate vaccine (7vPnC) when measured 1 month after the infant series.<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).;Timepoint(s) of evaluation of this end point: 1 month after the infant series (7 months of age)

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1 month after toddler dose (16 months of age);Secondary end point(s): The secondary 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 toddler dose