Last updated: 07/17/2024 15:15:26
Primary vaccination study with a pneumococcal conjugate vaccine in healthy children 6 to 12wks of age
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A, Infanrix hexa and Rotarix
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Antibody concentrations against pneumococcal vaccine serotypes
Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5
Antibody concentrations against Protein D
Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5
Secondary outcomes:
Opsonophagocytic titer against pneumococcal vaccine serotypes
Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5
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
Antibody concentrations against pneumococcal cross-reactive serotypes
Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5
Opsonophagocytic titer against pneumococcal cross-reactive serotypes
Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of subjects seropositive against vaccine pneumococcal serotypes
Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5
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
Number of subjects seropositive against cross-reactive pneumococcal serotypes
Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5
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
Number of subjects seropositive for anti-Protein D antibodies
Timeframe: One month after the administration of the 3rd vaccine dose i.e. Month 5
Number of subjects reporting any and grade 3 solicited local Adverse Events (AEs)
Timeframe: Within 4 days following any vaccine dose
Number of subjects reporting any, grade 3 and related solicited general AEs
Timeframe: Within 4 days following any vaccine dose
Number of subjects reporting any unsolicited AEs
Timeframe: Within 31 days after any vaccine dose
Number of subjects reporting any serious adverse events (SAEs)
Timeframe: Up to Month 5
Interventions:
Enrollment:
230
Primary completion date:
2008-31-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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.
Ruiz-Palacios GM (2011) Immunogenicity, reactogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Mexican infants. Hum Vaccin. 7(11):1137-1145.
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 et al. (2016) Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. [Epub ahead of print]
Medical condition
Infections, Streptococcal
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
July 2007 to March 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Male or female subjects between and including 6-12 weeks of age at the time of the first vaccination.
Exclusion criteria:
- 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.
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2008-31-03
Actual study completion date
2008-31-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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