Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule

NCT ID: NCT00307034

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 351 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-01
• Study Completion Date: 2007-01-25

Brief Summary

Assess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of age) and after the complete 2, 4, 11 months schedule when co-administered with DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (according to national recommendations)

Detailed Description

Total anticipated: 300 subjects (150/group). 2-dose group - 10-valent pneumococcal vaccine + DTPa combined vaccine (2, 4, 11 months); Comparator group - 10-valent pneumococcal vaccine (2, 3, 4, 11 months) + DTPa combined vaccine (2, 4, 11 months). 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: NONE

Study Groups

2-dose group

Subjects receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine at 2-4-11 months of age, co-administered with DTPa-combined vaccine (Infanrix hexa or Infanrix IPV/Hib) at 2-4-11 months of age.

Group Type: EXPERIMENTAL

GSK Biologicals' 10-valent pneumococcal conjugate vaccine.

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule).

Infanrix hexa.

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses (2-4-11 months of age schedule).

Infanrix-IPV/Hib.

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses (2-4-11 months of age schedule).

Comparator group

Subjects receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine at 2-3-4-11 months of age, co-administered with DTPa-combined vaccine (Infanrix hexa or Infanrix IPV/Hib) at 2-4-11 months of age.

Group Type: EXPERIMENTAL

GSK Biologicals' 10-valent pneumococcal conjugate vaccine.

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule).

Infanrix hexa.

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses (2-4-11 months of age schedule).

Infanrix-IPV/Hib.

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses (2-4-11 months of age schedule).

Interventions

GSK Biologicals' 10-valent pneumococcal conjugate vaccine.

Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule).

Intervention Type: BIOLOGICAL

Infanrix hexa.

Intramuscular injection, 3 doses (2-4-11 months of age schedule).

Intervention Type: BIOLOGICAL

Infanrix-IPV/Hib.

Intramuscular injection, 3 doses (2-4-11 months of age schedule).

Intervention Type: BIOLOGICAL

Other Intervention Names

DTPa-HBV-IPV/Hib; DTPa-IPV/Hib

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, 8 and 16 weeks (56-120 days) of age at the time of the first vaccination.
• 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.
• Born after a gestation period of 36 to 42 weeks.

Exclusion Criteria

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) and ending 30 days after the last dose, with exception of BCG vaccination which can be given after the 1 month post-dose 2 or 3 (2-4-11 or 2-3-4-11 months of age schedule) blood sampling and a minimum of 30 days before the pre-booster dose blood sampling.
• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae.
• History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, and/or invasive pneumococcal diseases.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
• 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 since birth or planned administration during the study period.

• Minimum Eligible Age: 8 Weeks
• Maximum Eligible Age: 16 Weeks
• 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

Hvidovre, , Denmark

GSK Investigational Site

Morvik, , Norway

GSK Investigational Site

Oslo, , Norway

GSK Investigational Site

Dolný Kubín, , Slovakia

GSK Investigational Site

Ružomberok, , Slovakia

GSK Investigational Site

Gothenburg, , Sweden

GSK Investigational Site

Örebro, , Sweden

GSK Investigational Site

Umeå, , Sweden

Countries

Denmark; Norway; Slovakia; Sweden

References

Schuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the 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. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. 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. Prevention of invasive pneumococcal disease and meningitis with PHiD-CV when used according to a 2+1 schedule. Abstract presented at the Meningitis Research Foundation Conference (MRFC). London, UK, 11-12 November 2009.

Reference Type: BACKGROUND

Silfverdal SA, Hogh B, Bergsaker MR, Skerlikova H, Lommel P, Borys D, Schuerman L. Immunogenicity of a 2-dose priming and booster vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine. Pediatr Infect Dis J. 2009 Oct;28(10):e276-82. doi: 10.1097/INF.0b013e3181b48ca3.

Reference Type: BACKGROUND

PMID: 20118683 (View on PubMed)

Study Documents

Document Type: Study Protocol

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

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Document Type: Dataset Specification

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

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Document Type: Informed Consent Form

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: Statistical Analysis Plan

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

View Document

Related Links

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Other Identifiers

105539

Identifier Type: -

Identifier Source: org_study_id