A Clinical Study Evaluating the Impact of a 13-Valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization With Vaccine Serotypes of Streptococcus pneumoniae in Healthy Infants in Israel

• Conditions: Prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 5 years of age.; MedDRA version: 14.1Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2008-003708-77-Outside-EU/EEA
• Lead Sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-07
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1864

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1864
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 vaccine.
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with a pneumococcal conjugate vaccine.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression including treatment with systemic steroids, anti metabolites, chemotherapy and immunomodulatory agents.
6. History of culture-proven invasive disease caused by S pneumoniae.
7. Major known congenital malformation or serious chronic disorders.
8. Significant neurologic disorder including congenital neurological disease in siblings of the subject or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant
disorder. 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; eg, Synagis®).
10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
11. 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: To demonstrate that 13vPnC reduces newly identified nasopharyngeal acquisitions of S pneumoniae serotypes 6A and 19A combined compared with 7vPnC from 1 month<br>after the infant series to 24 months of age.;Secondary Objective: To assess whether 13vPnC reduces the prevalence of nasopharyngeal colonization with S pneumoniae serotypes 6A and 19A as a group compared with 7vPnC at 18 months of age.<br>To assess whether 13vPnC reduces the prevalence of nasopharyngeal colonization with S pneumoniae serotypes 6A and 19A as a group compared with 7vPnC from 1 month after the infant series to 24 months of age.;Primary end point(s): The primary endpoint is the proportion of subjects with a new acquisition for either serotype 6A or 19A from 1 month after the infant series to 24 months of age.;Timepoint(s) of evaluation of this end point: From 1 month after the infant series to 24 months of age.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints are the proportion of cultures testing positive for serotypes 6A or 19A as a group measured at 18 months of age and from 1 month after the infant series to 24 months of age.;Timepoint(s) of evaluation of this end point: From 1 month after the infant series to 24 months of age.