Phase 4 N=476 Randomized Prevention

Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine

Haemophilus Influenzae Type b · Neisseria Meningitidis · Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine

Bottom Line

View on ClinicalTrials.gov: NCT00454987 ↗

Enrolled (actual)

476

Serious AEs

0.4%

Results posted

Dec 2015

Primary outcome: Primary: Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8 — 12; 3; 200; 63 Subjects

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Menitorix (Biological); Infanrix IPV (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Oct 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8	12; 3; 200; 63; 163; 39	—
PRIMARY Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128	2; 0; 182; 55; 87; 17	—
PRIMARY rSBA-MenC Antibody Titers	4.7; 4.2; 616.1; 983.9; 64.3; 30.8	—
PRIMARY Number of Subjects With rSBA-MenC Antibody Titers ≥1:8	16; 2; 222; 73; 175; 48	—
PRIMARY Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 for Meningitec+Hiberix Group	30	—
PRIMARY Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128	2; 0; 182; 55; 87; 17	—
PRIMARY Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 for Meningitec+Hiberix Group	11	—
PRIMARY rSBA-MenC Antibody Titers	4.7; 4.2; 616.1; 983.9; 64.3; 30.8	—
PRIMARY rSBA-MenC Antibody Titers for Meningitec+Hiberix Group	15.9	—
PRIMARY Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8	10; 2; 192; 55; 156; 34	—
PRIMARY Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128	2; 0; 182; 55; 87; 17	—
PRIMARY rSBA-MenC Antibody Titers	4.7; 4.2; 616.1; 983.9; 64.3; 30.8	—
PRIMARY Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)	84; 25; 204; 58; 199; 45	—
PRIMARY Concentration of Anti-PRP Antibodies	0.149; 0.180; 12.715; 1.776; 1.276; 0.380	—
PRIMARY Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL	77; 24; 14; 9; 196; 48	—
PRIMARY Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL for Meningitec+Hiberix Group	62; 28	—
PRIMARY Concentration of Anti-PRP Antibodies	0.149; 0.180; 12.715; 1.776; 1.276; 0.380	—
PRIMARY Concentration of Anti-PRP Antibodies for Meningitec+Hiberix Group	0.668	—
PRIMARY Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL	77; 24; 14; 9; 196; 48	—
PRIMARY Concentration of Anti-PRP Antibodies	0.149; 0.180; 12.715; 1.776; 1.276; 0.380	—
PRIMARY Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)	19; 4; 8; 1; 202; 63	—
PRIMARY Concentration of Anti-PSC Antibodies	0.19; 0.16; 9.41; 11.88; 0.76; 0.85	—
PRIMARY Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL	19; 3; 7; 1; 194; 54	—
PRIMARY Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL for Meningitec+Hiberix Group	4; 0	—
PRIMARY Concentration of Anti-PSC Antibodies	0.19; 0.16; 9.41; 11.88; 0.76; 0.85	—
PRIMARY Concentration of Anti-PSC Antibodies for Meningitec+Hiberix Group	0.16	—
PRIMARY Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL	19; 3; 7; 1; 194; 54	—
PRIMARY Concentration of Anti-PSC Antibodies	0.19; 0.16; 9.41; 11.88; 0.76; 0.85	—
PRIMARY Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)	11; 3; 63; 20; 34; 10	—
PRIMARY Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies	3.4; 3.4; 45.2; 36.5; 5.1; 3.9	—
PRIMARY Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL	9; 2; 42; 11; 24; 5	—
PRIMARY Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies	3.4; 3.4; 45.2; 36.5; 5.1; 3.9	—
PRIMARY Number of Subjects With Serious Adverse Events (SAEs)	0; 0	—
PRIMARY Number of Subjects With SAE(s)	1; 0; 0	—
PRIMARY Number of Subjects With SAE(s)	1; 0; 0	—
PRIMARY Number of Subjects With SAE(s)	1; 0; 0	—

Summary

The purpose of this study is to evaluate the long-term antibody persistence at 12, 24 and 48 months after the administration of a booster dose of Menitorix™, given at 12-15 months of age. The children had previously received 3 doses of Menitorix™ and Infanrix IPV™ or Meningitec™ and Pediacel™ in infancy. In addition, the antibody persistence is to be investigated in children of 40-43 months of age who received a 3-dose primary vaccination of a MenC conjugate vaccine and a Hib containing vaccine in infancy without a booster dose of MenC conjugate and Hib vaccine in the second year of life. This protocol posting deals with objectives & outcome measures of the extension phases at 12, 24 and 48 months after the booster phase. The links to objectives and outcome measures of the primary phase & booster phase at 12 to 15 months are provided below: https://www.gsk-studyregister.com/study/2747 (Primary phase) https://www.gsk-studyregister.com/study/2755 (Booster phase)

Eligibility Criteria

Inclusion Criteria

Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3:

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female between and including 24 and 31 months of age at the time of Visit 1, between and including 40 and 43 months of age at Visit 2 and between and including 60 and 64 months at Visit 3.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Having completed the booster vaccination study 104056.

Subjects of group NoBoost at Visit 2 (UK only):

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female between and including 40 and 43 months of age at Visit 2.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Having received a 3-dose primary vaccination with a MenC conjugate vaccine and a Hib containing vaccine before the age of 8 months.

Exclusion Criteria

Previous administration of booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study 104056.
History of H. influenzae type b or meningococcal diseases.
For UK subjects of groups HibMenC and LicMenC only: previous administration of a booster dose of a pertussis-containing vaccine except booster study vaccines during the study 104056.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00454987). 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.