Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months

Browse trials for

• Hepatitis A 2,709
• Hepatitis 3,380

Keywords

• Hepatitis A

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 468 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Study arms

• Active comparator
  Havrix Group

  Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.

  Biological: Havrix™

• Experimental
  Infanrix + ActHIB→Havrix Group

  Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.

  Biological: Havrix™ · Biological: Infanrix™ · Biological: ActHIB™

• Active comparator
  Havrix + Infanrix + ActHIB Group

  Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.

  Biological: Havrix™ · Biological: Infanrix™ · Biological: ActHIB™

Interventions

• BiologicalHavrix™

  2 intramuscular injections, 6 months apart

• BiologicalInfanrix™

  1 intramuscular injection

• BiologicalActHIB™

  1 intramuscular injection

Primary outcomes

1. Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix

   Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).

   Time frame: 31 days following the second dose of Havrix™

2. Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects

   Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.

   Time frame: 31 days following the administration of Infanrix™ and ActHIB

3. Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)

   Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.

   Time frame: 31 days following the administration of Infanrix™ and ActHIB

Secondary outcomes

1. Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)

   GMCs are expressed as International Units per milliliter (IU/mL).

   Time frame: 31 days following the administration of Infanrix™ and ActHIB

2. Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)

   GMCs are expressed as microgram/milliliter (µg/mL).

   Time frame: 31 days following the administration of Infanrix™ and ActHIB

3. Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)

   Seropositivity is defined as antibody concentrations ≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL) for anti-PT, anti-FHA and anti-PRN antibodies and as antibody concentrations ≥ 0.15 microgram/milliliter (µg/mL) for anti-PRP antibodies.

   Time frame: 31 days following the administration of Infanrix™ and ActHIB

4. Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix

   Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).

   Time frame: 31 days following the first dose of Havrix™

5. Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix

   Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).

   Time frame: 31 days following the first dose of Havrix™

6. Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix

   Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).

   Time frame: 31 days following the second dose of Havrix™

7. Number of Subjects With Vaccine Response to Havrix™.

   Vaccine response to Havrix is defined as post-vaccination anti-HAV antibody concentrations ≥ 15 mIU/mL in initially seronegative subjects or a ≥ 2-fold increase above the pre-vaccination anti-HAV antibody concentration in initially seropositive subjects.

   Time frame: 31 days following the second dose

8. Number of Subjects Reporting Solicited Local Adverse Events (AEs)

   Solicited local AEs assessed include pain, redness and swelling. Data across doses are presented in the table.

   Time frame: 4-day period following each dose of study vaccine(s)

9. Number of Subjects Reporting Solicited General Adverse Events (AEs)

   Solicited general AEs assessed include drowsiness, axillary fever ≥ 37.5°C, irritability and loss of appetite. Data across doses are presented in the table.

   Time frame: 4-day period following each dose of study vaccine(s)

10. Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Time frame: 31-day period following each dose of study vaccine(s)

11. Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events

    Since the related information about medically significant events was not specifically collected and new chronic illnesses were only collected in the extended safety follow-up phase, all unsolicited adverse events (AEs) throughout the study are reported in the table without identifying which event was a medically significant or new chronic illness.

    Time frame: Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase.

Baseline characteristics

Publications

• Trofa AF, Klein NP, Paul IM, Michaels MG, Goessler M, Chandrasekaran V, Blatter M. Immunogenicity and safety of an inactivated hepatitis A vaccine when coadministered with Diphtheria-tetanus-acellular pertussis and haemophilus influenzae type B vaccines in children 15 months of age. Pediatr Infect Dis J. 2011 Sep;30(9):e164-9. doi: 10.1097/INF.0b013e31821b8a7d. PubMed 21494175 ↗

Related links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.