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Phase 3 N=230 Prevention

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 12wks of Age

Infections, Streptococcal · Streptococcus Pneumoniae Vaccines

Enrolled (actual)
230
Serious AEs
6.5%
Results posted
May 2012
Primary outcome: Primary: Antibody Concentrations Against Pneumococcal Vaccine Serotypes — 2.13; 3.04; 3.24; 1.32 microgram per milliliter

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Synflorix (Biological); Infanrix hexa (Biological); Rotarix (Biological)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Mar 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Antibody Concentrations Against Pneumococcal Vaccine Serotypes
2.13; 3.04; 3.24; 1.32; 3.72; 3.71
PRIMARY
Antibody Concentrations Against Protein D
2923.2
SECONDARY
Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes
94.1; 670.8; 148.8; 345.4; 4435.4; 1186.1
SECONDARY
Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter
219; 218; 218; 203; 218; 218
SECONDARY
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes
0.28; 0.26
SECONDARY
Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes
159.2; 11.6
SECONDARY
Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes
219; 218; 218; 212; 218; 218
SECONDARY
Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes
83; 93; 93; 76; 96; 96
SECONDARY
Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes
203; 198
SECONDARY
Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes
69; 19
SECONDARY
Number of Subjects Seropositive for Anti-Protein D Antibodies
219
SECONDARY
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
196; 80; 91; 0; 178; 10
SECONDARY
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
55; 5; 55; 156; 7; 153
SECONDARY
Number of Subjects Reporting Any Unsolicited AEs
174
SECONDARY
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
15

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00489554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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