Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Infants in Mexico

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

• Registration Number: EUCTR2009-017122-39-Outside-EU/EEA
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-10
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 225

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 relevant study procedures during study participation.
5. Weight of 3.5 kilograms (kg) or greater at the time of enrollment.

Are the trial subjects under 18? yes
Number of subjects for this age range: 225
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, Haemophilus influenza type b (Hib) conjugate, diphtheria, tetanus, pertussis, polio, measles, mumps, rubella or rotavirus vaccines.
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, rotavirus, measles, mumps, rubella or pneumococcal 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 S pneumoniae.
7. Major known congenital malformation or serious chronic disorder.
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 or interventional trial. Participation in purely observational studies is acceptable.
11. Infant who is a direct descendant (child, 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
Main Objective: To assess the pneumococcal immune responses induced by 13 valent pneumococcal conjugate vaccine (13vPnC) when measured 1 month after the 3-dose 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).<br>;Secondary Objective: To assess the pneumococcal immune responses induced by 13vPnC when measured 1 month after the second dose of the infant series.<br>To assess the pneumococcal immune responses induced by 13vPnC when measured 1 month after the toddler dose<br>;Primary end point(s): Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (=) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series;Timepoint(s) of evaluation of this end point: 1 month after the infant series (7 months of age)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level =0.35mcg/mL, 1 Month After Dose 2 of the Infant Series<br><br>Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Concentration=0.35mcg/mL, 1 Month After the Toddler Dose;Timepoint(s) of evaluation of this end point: 1 month after dose 2 of the infant series (5 months of age)<br><br>1 month after the toddler dose (13 months of age)