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Phase 3 N=4,003 Randomized Double-blind Prevention

Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants

Haemophilus Influenzae Type b

Enrolled (actual)
4,003
Serious AEs
4.1%
Results posted
Aug 2013
Primary outcome: Primary: Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL — 1536; 265; 234; 1291 Subjects

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108) (Biological); ActHIB™ (Biological); Pentacel™ (Biological); Pediarix™ (Biological); Prevnar 13™ (Biological); Rotarix™ (Biological); Engerix™-B (Biological); Infanrix™ (Biological)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Nov 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL
1536; 265; 234; 1291; 246; 198
PRIMARY
Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL)
393; 273; 249; 393; 274; 249
PRIMARY
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
5.193; 6.743; 3.640
PRIMARY
Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations
73.2; 71.9; 41.9; 111.6; 93.5; 51.9
PRIMARY
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations
2.515; 2.500; 2.442; 1.056; 1.008; 1.190
PRIMARY
Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA)
764; 264; 201; 762; 262; 213 <0.0001 sig
PRIMARY
Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value
246; 181; 164; 275; 188; 183
PRIMARY
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL
333; 231; 184
SECONDARY
Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations
2.72; 2.45; 1.88; 2.23; 2.44; 1.72
SECONDARY
Number of Subjects With Any Solicited Local Symptoms
918; 179; 163; 659; 127; 115
SECONDARY
Number of Subjects With Any Solicited General Symptoms
857; 164; 119; 1293; 250; 201
SECONDARY
Number of Subjects With Any Unsolicited Adverse Events (AEs).
882; 159; 138
SECONDARY
Number of Subjects With Serious Adverse Events (SAEs)
29; 4; 2
SECONDARY
Number of Subjects With AEs of Specific Interest (AESIs)
47; 12; 7
SECONDARY
Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA
706; 248; 165; 741; 250; 194
SECONDARY
Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL
789; 275; 249; 786; 275; 244
SECONDARY
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL
247; 172; 116; 336; 235; 186
SECONDARY
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations
3684.3; 3545.6; 1573.4
SECONDARY
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL
384; 268; 245; 382; 269; 243
SECONDARY
Antibody Titers for Poliovirus Types 1, 2 and 3
570.8; 620.9; 136.0; 471.8; 389.9; 210.9
SECONDARY
Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values
362; 257; 239; 362; 257; 239
SECONDARY
Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations
0.498; 0.467; 0.380; 48.782; 40.293; 37.543
SECONDARY
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL
268.3; 247.0; 156.4
SECONDARY
Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL
311; 199; 156; 306; 198; 154
SECONDARY
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL
328; 223; 171; 335; 235; 185
SECONDARY
Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8
106.2; 101.6; 25.1; 109.4; 89.5; 48.9
SECONDARY
Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8
294; 197; 124; 285; 196; 144
SECONDARY
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively.
322; 218; 173; 336; 236; 186
SECONDARY
Number of Subjects With Any Solicited Local Symptoms
918; 179; 163; 659; 127; 115
SECONDARY
Number of Subjects With Any Solicited General Symptoms
857; 164; 119; 1293; 250; 201
SECONDARY
Number of Subjects With AEs of Specific Interest (AESIs)
47; 12; 7
SECONDARY
Number of Subjects With Any Unsolicited Adverse Events (AEs).
882; 159; 138
SECONDARY
Number of Subjects With Serious Adverse Events (SAEs)
29; 4; 2
SECONDARY
Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations
41.3; 40.0; 22.7; 464.9; 492.5; 263.8

Summary

The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the vaccine, to address the relevant concomitant vaccine administrations and to provide a comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and 15-18 months of age. This study is designed with a primary and a booster phase.

Eligibility Criteria

Inclusion Criteria

  • Subjects for whom the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the requirements of the protocol (e.g., completion of the diary card, return for follow-up visits).
  • A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
  • Written informed consent obtained from the subject's parent/LAR.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of minimum 36 weeks.
  • Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.

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.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine and until 30 days after the booster dose.
  • Previous vaccination against Haemophilus influenzae type b, diphtheria, tetanus, pertussis, Pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.
  • History of Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus, and hepatitis B diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at time of enrollment. All vaccines can be administered to persons with a minor illness.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Concurrent participation in another clinical study, up to 30 days prior to study entry or 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 (pharmaceutical product or device).
  • Child in care.
  • History of intussusception.
  • History of uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception.
  • History of Severe Combined Immunodeficiency Disease.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01000974). 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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