Clinical trial NCT00547248: Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines
Official title: Booster Vaccination Course With the Pneumococcal Vaccine GSK 1024850A, DTPw-HBV/Hib and OPV or IPV in Children Who Completed the Primary Vaccination Course in Study 107007
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Keywords: Booster vaccination.
Immunogenicity
Pneumococcal vaccine
Safety
Pneumococcal disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-22
Enrollment: 756
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off
timeFrame: Within the 4-day (Days 0-3) period after booster vaccination
Secondary outcomes:
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: Within the 4-day (Days 0-3) period after booster vaccination
measure: Number of Subjects With Any and Grade 3 Solicited General Symptoms
timeFrame: Within the 4-day (Days 0-3) period after booster vaccination
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: Within the 31-day (Days 0-30) period after booster vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: Throughout the active phase of the study (Month 0 to Month 1)
measure: Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Antibody Concentrations to Protein D (Anti-PD)
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Anti-Bordetella Pertussis (BPT) Antibody Concentrations
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Anti-polio Type 1, 2 and 3 Antibody Titers
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off
timeFrame: Prior to (Month 0) and one month after booster vaccination (Month 1)
measure: Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)
timeFrame: One month after booster vaccination (Month 1)
Other outcomes:
Locations:
city: Muntinlupa
country: Philippines
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Trzebnica
country: Poland
facility: GSK Investigational Site
city: Tuchola
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.