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

Purpose

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)

Condition	Intervention	Phase
Pneumococcal Infections	Biological: GSK Biologicals' 10-valent pneumococcal conjugate vaccine. Biological: Infanrix hexa. Biological: Infanrix-IPV/Hib.	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	An Open, Randomized, Phase IIIa Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Administered Intramuscularly According to a 2-4-11 Months Vaccination Schedule

Resource links provided by NLM:

MedlinePlus related topics: Pneumococcal Infections

Drug Information available for: Boostrix Heptavalent pneumococcal conjugate vaccine Adacel Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL. [ Time Frame: 1 month post-dose 2 (2-4-11 months of age schedule) of GSK Biologicals' 10-valent pneumococcal conjugate vaccine. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Concentrations of antibodies against vaccine pneumococcal serotypes. [ Time Frame: 1 month post-dose 2 or 3 (2-4-11 or 2-3-4-11 months of age schedule), prior to and 1 month post-booster dose of pneumococcal conjugate vaccine. ] [ Designated as safety issue: No ]
Opsonophagocytic activity against vaccine pneumococcal serotypes. [ Time Frame: 1 month post-dose 2 or 3 (2-4-11 or 2-3-4-11 months of age schedule), prior to and 1 month post-booster dose of pneumococcal conjugate vaccine. ] [ Designated as safety issue: No ]
Concentrations of antibodies against protein D. [ Time Frame: 1 month post-dose 2 or 3 (2-4-11 or 2-3-4-11 months of age schedule), prior to and 1 month post-booster dose of pneumococcal conjugate vaccine. ] [ Designated as safety issue: No ]
Anti-diphtheria and anti-tetanus toxoids, anti-PRP, anti-pertussis, anti-HBs antibody concentrations and anti-polio type 1, 2 and 3 titres. [ Time Frame: 1 month post-dose 2, prior to and 1 month post-booster dose of DTPa-combined vaccine. ] [ Designated as safety issue: No ]
Occurrence of solicited local symptoms. [ Time Frame: Within 4 days after each vaccination. ] [ Designated as safety issue: Yes ]
Occurrence of solicited general symptoms [ Time Frame: Within 4 days after each vaccination. ] [ Designated as safety issue: Yes ]
Occurrence of unsolicited adverse events. [ Time Frame: Within 31 days after each vaccination. ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events. [ Time Frame: Throughout the whole study period. ] [ Designated as safety issue: Yes ]

Enrollment:	351
Study Start Date:	January 2006
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Biological: 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). Biological: Infanrix hexa. Intramuscular injection, 3 doses (2-4-11 months of age schedule). Other Name: DTPa-HBV-IPV/Hib Biological: Infanrix-IPV/Hib. Intramuscular injection, 3 doses (2-4-11 months of age schedule). Other Name: DTPa-IPV/Hib
Experimental: 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.	Biological: 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). Biological: Infanrix hexa. Intramuscular injection, 3 doses (2-4-11 months of age schedule). Other Name: DTPa-HBV-IPV/Hib Biological: Infanrix-IPV/Hib. Intramuscular injection, 3 doses (2-4-11 months of age schedule). Other Name: DTPa-IPV/Hib

Detailed Description:

Total: 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.

Eligibility

Ages Eligible for Study:	8 Weeks to 16 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307034

Locations

Denmark
GSK Investigational Site
Hvidovre, Denmark, 2650
Norway
GSK Investigational Site
Morvik, Norway, 5125
GSK Investigational Site
Oslo, Norway, 0130
Slovakia
GSK Investigational Site
Dolny Kubin, Slovakia, 026 01
GSK Investigational Site
Ruzomberok, Slovakia, 034 01
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-416 73
GSK Investigational Site
Umeå, Sweden, SE-901 85
GSK Investigational Site
Örebro, Sweden, SE-702 11

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications:

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.

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.

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.

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.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00307034 History of Changes
Other Study ID Numbers:	105539
Study First Received:	March 24, 2006
Last Updated:	November 21, 2012
Health Authority:	Slovakia: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:

Primary vaccination
Pneumococcal disease
Safety
Booster vaccination

Immunogenicity
Pneumococcal vaccine
Dose comparison

Additional relevant MeSH terms:

Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 16, 2013