Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines

NCT ID: NCT00547248

Last Updated: 2019-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 756 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-22
• Study Completion Date: 2008-10-07

Brief Summary

The purpose of this observer blind study is to assess the safety in terms of fever >39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and OPV or IPV vaccines. Subjects participating in this study should have received three doses of pneumococcal conjugate vaccine in the primary study.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00344318)

Detailed Description

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

Conditions

Infections, Streptococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group

Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.

Group Type: EXPERIMENTAL

Synflorix

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose

Tritanrix-HepB

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose

Hiberix

Intervention Type: BIOLOGICAL

Reconstituted with Tritanrix-Hep B before injection

Polio Sabin

Intervention Type: BIOLOGICAL

Oral, 1 dose

Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group

Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.

Group Type: ACTIVE_COMPARATOR

Tritanrix-HepB

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose

Hiberix

Intervention Type: BIOLOGICAL

Reconstituted with Tritanrix-Hep B before injection

Polio Sabin

Intervention Type: BIOLOGICAL

Oral, 1 dose

Prevenar (Wyeth)

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose

Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group

Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.

Group Type: EXPERIMENTAL

Synflorix

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose

Tritanrix-HepB

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose

Hiberix

Intervention Type: BIOLOGICAL

Reconstituted with Tritanrix-Hep B before injection

Poliorix

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose

Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group

Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix and Poliorix™ at 12-18 months of age.

Group Type: ACTIVE_COMPARATOR

Tritanrix-HepB

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose

Hiberix

Intervention Type: BIOLOGICAL

Reconstituted with Tritanrix-Hep B before injection

Poliorix

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose

Prevenar (Wyeth)

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose

Interventions

Synflorix

Intramuscular injection, 1 dose

Intervention Type: BIOLOGICAL

Tritanrix-HepB

Intramuscular injection, 1 dose

Intervention Type: BIOLOGICAL

Hiberix

Reconstituted with Tritanrix-Hep B before injection

Intervention Type: BIOLOGICAL

Polio Sabin

Oral, 1 dose

Intervention Type: BIOLOGICAL

Poliorix

Intramuscular injection, 1 dose

Intervention Type: BIOLOGICAL

Prevenar (Wyeth)

Intramuscular injection, 1 dose

Intervention Type: BIOLOGICAL

Other Intervention Names

Pneumococcal conjugate vaccine GSK1024850A; DTPw-HBV vaccine; Hib vaccine; OPV; IPV; Pneumococcal conjugate vaccine

Eligibility Criteria

Inclusion Criteria

• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• A male or female between, and including, 12-18 months of age at the time of the booster vaccination and who previously participated in study 107007 and received three doses of pneumococcal conjugate vaccine.
• Written informed consent obtained from the parent or guardian of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

• Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines.
• Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit.
• Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b vaccine other than the study vaccines from study 107007.
• History of, or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b diseases.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
• Acute disease at the time of enrolment.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious chronic illness.
• Administration of immunoglobulins and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

City of Muntinlupa, , Philippines

GSK Investigational Site

Gdansk, , Poland

GSK Investigational Site

Lodz, , Poland

GSK Investigational Site

Trzebnica, , Poland

GSK Investigational Site

Tuchola, , Poland

GSK Investigational Site

Wroclaw, , Poland

GSK Investigational Site

Wroclaw, , Poland

Countries

Philippines; Poland

References

Bermal N, Szenborn L, Edison A, Hernandez M, Pejcz J, Majda-Stanislawska E, Gatchalian S, Fanic A, Dieussaert I, Schuerman L. Safety and immunogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine coadministered with DTPw-HBV/Hib and poliovirus vaccines. Pediatr Infect Dis J. 2011 Jan;30(1):69-72. doi: 10.1097/INF.0b013e3181f2da06.

Reference Type: BACKGROUND

PMID: 20980933 (View on PubMed)

Bermal N et al. Primary and booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) co-administered with DTPw-HBV/Hib and polio vaccines. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

Reference Type: BACKGROUND

Nancy B et al. Booster dose of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) administered to children in the Philippines: antibody responses and safety. Abstract presented at the 13th Asian Pacific Congress of Pediatrics (APCP). Shanghai, China, 14-18 October 2009.

Reference Type: BACKGROUND

Schuerman L et al. Immune responses against cross-reactive pneumococcal serotypes 6A and 19A with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

Reference Type: BACKGROUND

Schuerman L et al. Immune responses to the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) appear not influenced by co-administration with DTPw-combination vaccine. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

Reference Type: BACKGROUND

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

109509

Identifier Type: -

Identifier Source: org_study_id