Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Infanrix Hexa and Rotarix

GlaxoSmithKline1 site in 1 country230 target enrollmentSeptember 18, 2007

ConditionsInfections, Rotavirus

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Infections, Rotavirus
Sponsor: GlaxoSmithKline
Enrollment: 230
Locations: 1
Primary Endpoint: Concentration of Anti-Protein D Antibodies
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Taiwanese infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine and rotavirus vaccine in children during the first 6 months of life.

Detailed Description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Registry

clinicaltrials.gov

Start Date

September 18, 2007

End Date

June 6, 2008

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects between, and including 6-8 weeks of age at the time of the first vaccination.
•Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
•Written informed consent obtained from the parent(s) or guardian(s) of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria

•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
•Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccines and ending 7 days after dose 1 and dose 2 and one month after dose
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
•A family history of congenital or hereditary immunodeficiency.
•Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae; with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations (e.g. Hepatitis B and Bacillus Calmette-Guérin (BCG)).
•History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b disease.
•Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).

Outcomes

Primary Outcomes

Concentration of Anti-Protein D Antibodies

Time Frame: One month after the third dose

Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).

Concentration of Anti-Pneumococcal Antibodies

Time Frame: One month after the third dose

Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Secondary Outcomes

Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value(Before the first dose (pre) and one month after (post) the third dose)
Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value(One month after the third dose)
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value(Before the first dose (pre) and one month after (post) the third dose)
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value(One month after the third dose)
Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value(One month after the third dose)
Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value(One month after the third dose)
Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value(One month after the third dose)
Number of Subjects Reporting Serious Adverse Events (SAE)(Up to one month after the third dose)
Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value(One month after the third dose)
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value(One month after the third dose)
Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value(Four months after the administration of the second dose of Rotarix™ vaccine)
Number of Subjects Reporting Unsolicited Adverse Events (AE)(During the 31-day (Day 0-30) period after each dose)
Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value(One month after the third dose)
Number of Subjects Reporting Solicited Symptoms(During the 4-day (Day 0-3) period after each dose)