Clinical trial NCT00489554: Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 12wks of Age
Official title: Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Infanrix Hexa and Rotarix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Streptococcus Pneumoniae Vaccines
Keywords: Primary vaccination
Safety
Pneumococcal vaccine.
Pneumococcal disease
Immunogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-06-21
Enrollment: 230
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Mexican infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine (Infanrix hexa) and rotavirus vaccine (Rotarix) in children during the first 6 months of age.

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

Eligibility criteria: Inclusion Criteria:

* Male or female subjects between and including 6-12 weeks of age at the time of the first vaccination.
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
* 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 inclusive.

Exclusion Criteria:

* Use of any investigational or non-registered product (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 one month before each dose of vaccines and ending 7 days after dose 1 and dose 2 and one month after dose 3.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* A family history of congenital or hereditary immunodeficiency.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae; with the exception of vaccines where the first dose may be given at birth within the first two weeks of life according to national recommendations (e.g. Hepatitis B and BCG).
* History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b disease.
* Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* History of any neurological disorders or seizures.
* Major congenital defects or serious chronic illness.
* Acute disease at the time of enrolment.

Primary outcomes:
measure: Antibody Concentrations Against Pneumococcal Vaccine Serotypes
timeFrame: One month after the administration of the 3rd vaccine dose i.e. Month 5
measure: Antibody Concentrations Against Protein D
timeFrame: One month after the administration of the 3rd vaccine dose i.e. Month 5
Secondary outcomes:
measure: Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes
timeFrame: One month after the administration of the 3rd vaccine dose i.e. Month 5
measure: Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter
timeFrame: One month after the administration of the 3rd vaccine dose i.e. Month 5
measure: Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes
timeFrame: One month after the administration of the 3rd vaccine dose i.e. Month 5
measure: Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes
timeFrame: One month after the administration of the 3rd vaccine dose i.e. Month 5
measure: Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes
timeFrame: One month after the administration of the 3rd vaccine dose i.e. Month 5
measure: Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes
timeFrame: One month after the administration of the 3rd vaccine dose i.e. Month 5
measure: Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes
timeFrame: One month after the administration of the 3rd vaccine dose i.e. Month 5
measure: Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes
timeFrame: One month after the administration of the 3rd vaccine dose i.e. Month 5
measure: Number of Subjects Seropositive for Anti-Protein D Antibodies
timeFrame: One month after the administration of the 3rd vaccine dose i.e. Month 5
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
timeFrame: Within 4 days following any vaccine dose
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
timeFrame: Within 4 days following any vaccine dose
measure: Number of Subjects Reporting Any Unsolicited AEs
timeFrame: Within 31 days after any vaccine dose
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs)
timeFrame: Up to Month 5
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ruiz-Palacios G et al. Immunogenicity, safety and reactogenicity of the new 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) in Mexican infants. Abstract presented at the XIII Congreso Latinoamericano de Infectología Pediátrica (SLIPE). Guayaquil, Ecuador, 12-15 August 2009.
citation: Ruiz-Palacios GM, Guerrero ML, Hernandez-Delgado L, Lavalle-Villalobos A, Casas-Munoz A, Cervantes-Apolinar Y, Moreira M, Schuerman L. Immunogenicity, reactogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Mexican infants. Hum Vaccin. 2011 Nov;7(11):1137-45. doi: 10.4161/hv.7.11.17984. Epub 2011 Nov 1.
citation: 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.
citation: 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.
citation: Silfverdal SA, Coremans V, Francois N, Borys D, Cleerbout J. Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30.