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

NCT00307034 | Completed Phase 3 Results

• 1 other identifier: 105539
• Study Type: interventional
• Target: 351
• Locations: 4 countries
• Sites: 8

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)

Conditions

Infections, Streptococcal

Keywords

Primary vaccination; Pneumococcal disease; Safety; Booster vaccination; Immunogenicity; Pneumococcal vaccine; Dose comparison

Outcome Measures

Primary Outcomes (1)

• Number of Seroprotected Subjects Against Pneumococcal Serotypes

  A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs). The results presented for the Group 1 correspond to the primary outcome.

  One month post-dose 2 (Month 3) administration of Synflorix™ vaccine

Secondary Outcomes (16)

• Number of Seroprotected Subjects Against Pneumococcal Serotypes

  One month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine

• Antibody Concentrations Against Pneumococcal Serotypes

  One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine

• Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes

  One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine

• Antibody Concentrations Against Protein D (Anti-PD)

  One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine

• Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids

  One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine

Study Arms (2)

2-dose group

EXPERIMENTAL

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.; Biological: Infanrix hexa.; Biological: Infanrix-IPV/Hib.

Comparator group

EXPERIMENTAL

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.; Biological: Infanrix hexa.; Biological: Infanrix-IPV/Hib.

Interventions

GSK Biologicals' 10-valent pneumococcal conjugate vaccine. BIOLOGICAL

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

2-dose group; Comparator group

Infanrix hexa. BIOLOGICAL

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

Also known as: DTPa-HBV-IPV/Hib

2-dose group; Comparator group

Infanrix-IPV/Hib. BIOLOGICAL

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

Also known as: DTPa-IPV/Hib

2-dose group; Comparator group

Eligibility Criteria

• Age: 8 Weeks - 16 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Hvidovre, 2650, Denmark

Location

GSK Investigational Site

Morvik, 5125, Norway

Location

GSK Investigational Site

Oslo, 0130, Norway

Location

GSK Investigational Site

Dolný Kubín, 026 01, Slovakia

Location

GSK Investigational Site

Ružomberok, 034 01, Slovakia

Location

GSK Investigational Site

Gothenburg, SE-416 73, Sweden

Location

GSK Investigational Site

Örebro, SE-702 11, Sweden

Location

GSK Investigational Site

Umeå, SE-901 85, Sweden

Location

Related Publications (4)

• 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.

  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.

  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.

  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.

  PMID: 20118683 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Streptococcal Infections; Pneumococcal Infections

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2006
• First Posted: March 27, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 25, 2007
• Last Updated: June 8, 2018
• Results First Posted: April 4, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

NO (2); SE (3); DK (1); SL (2)