Pneumococcal Vaccines Early and in Combination (PREVIX_COMBO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Menzies School of Health Research
Sponsor:
Information provided by (Responsible Party):
Menzies School of Health Research
ClinicalTrials.gov Identifier:
NCT01174849
First received: August 2, 2010
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to determine whether an early schedule of a combination of three doses of PHiD-CV and one dose of PCV13, is superior to three doses of either PCV13 or PHiD-CV.


Condition Intervention Phase
Otitis Media
Drug: Synflorix
Drug: Prevenar13
Drug: COMBO
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial of Pneumococcal Conjugate Vaccines Synflorix and Prevenar13 in Sequence or Alone in High-risk Indigenous Infants (PREV-IX_COMBO): Immunogenicity, Carriage and Otitis Media Outcomes

Resource links provided by NLM:


Further study details as provided by Menzies School of Health Research:

Primary Outcome Measures:
  • Immunogenicity [ Time Frame: 7 months of age ] [ Designated as safety issue: No ]
    At 7 months of age, the overall and serotype specific (particularly serotype 19A and HiD) a IgG Geometric Mean Concentration (GMC) b proportion of children with IgG GMC above threshold (0.35 microg/mL)


Secondary Outcome Measures:
  • nasopharyngeal carriage [ Time Frame: 7 months of age ] [ Designated as safety issue: No ]
    At 7 months of age, the proportion of children with any carriage of serotype 19A pneumococci

  • nasopharyngeal carriage [ Time Frame: 7 months of age ] [ Designated as safety issue: No ]
    At 7 months of age, the proportion of children with any carriage of non-capsular H. influenzae.

  • otitis media [ Time Frame: 7 months of age ] [ Designated as safety issue: No ]
    At 7 months of age, the proportion of children with any otitis media.


Estimated Enrollment: 425
Study Start Date: August 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Synflorix Drug: Synflorix
The 10-valent vaccine contains 1 µg of purified capsular polysaccharide of pneumococcal serotypes 1, 5, 6B, 7F, 9V, 14, and 23F conjugated to protein D, 3 µg of serotype 4 conjugated to protein D, 3 µg of serotype 18C conjugated to tetanus toxoid and 3 µg of serotype 19F conjugated to diphtheria toxoid.
Other Name: PHiD-CV
Active Comparator: Prevenar13 Drug: Prevenar13

The vaccine is a ready to use homogeneous white suspension for intramuscular injection, supplied as a pre-filled syringe.

Active ingredients

Each 0.5 mL dose contains:

2.2 μg of pneumococcal purified capsular polysaccharides for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F 4.4 μg of pneumococcal purified capsular polysaccharides for serotype 6B. Each serotype is individually conjugated to non-toxic diphtheria CRM197 protein and adsorbed on aluminium phosphate (0.565 mg). CRM197 is a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197) grown in a casamino acids and yeast extract-based medium.

Other Name: PCV13
Experimental: COMBO
COMBINATION SCHEDULE of comparator vaccine 1 and comparator vaccine 2 Synflorix at 1,2,4 months then Prevenar13 at 6 months.
Drug: COMBO
COMBINATION SCHEDULE of vaccine 1 and vaccine 2: Synflorix (PHiD-CV) at 1,2,4 months then Prevenar13 (PCV13) at 6 months of age.
Other Name: Combination schedule

Detailed Description:

Aboriginal children in the Northern Territory (NT) have high rates of otitis media caused by non-capsular H. influenzae (NCHi) and pneumococci. Pneumococcal conjugate vaccine has effectively reduced disease caused by the 7 serotypes. Rates of non-vaccine serotype otitis media (OM), particularly 19A is increasing, and NCHi continues to be a major pathogen in perforations. Parallels with pneumonia are highly probable in this population. Vaccines with expanded and early age protection are needed.

In early 2009 GSK's pneumococcal H. influenzae protein D conjugate vaccine (PHiD-CV) was licensed in Australia. Compared to the current vaccine, 7PCV, this vaccine offers protection from pneumococcal serotypes 1, 5, 7F as well as NCHi (which is a primary pathogen of OM, and possibly pneumonia). However by 2010, a new generation of Wyeth's 7PCV, PCV13 will also be licensed in Australia. Compared to PHiD-CV this vaccine offers protection from additional serotypes 3, 6A and 19A, however it does not offer protection from NCHi infection. There is no empirical evidence to suggest that either vaccine will have superior clinical efficacy for otitis media or pneumonia in high-risk children. The novel combination strategy proposed for this trial has the potential to provide the best of both vaccines.

  Eligibility

Ages Eligible for Study:   up to 38 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Indigenous infants

  • 4 to 6 weeks of age
  • Living in remote communities that have provided signed Expressions of Interest in participating in PREV-IX_COMBO trial
  • Intend to remain in their community until their baby is 7 months of age
  • Eligible for routine vaccinations.

Exclusion Criteria:

  • Prior adverse reaction to pneumococcal conjugate vaccines according to Australian Immunization Handbook.
  • Gestational age < 32 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174849

Contacts
Contact: Amanda J Leach, PhD +61 8 89228649 amanda.leach@menzies.edu.au

Locations
Australia, Northern Territory
Menzies School of Health Research Recruiting
Darwin, Northern Territory, Australia, 0811
Contact: Amanda J Leach, PhD    +61 8 89228196 ext 28649    amanda.leach@menzies.edu.au   
Principal Investigator: Amanda J Leach, PhD         
Sponsors and Collaborators
Menzies School of Health Research
Investigators
Principal Investigator: Amanda J Leach, PhD Menzies School of Health Research
  More Information

Publications:

Responsible Party: Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT01174849     History of Changes
Other Study ID Numbers: 605810, ACTRN12610000544077
Study First Received: August 2, 2010
Last Updated: October 10, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Menzies School of Health Research:
otitis media
pneumococcal vaccines
randomised controlled trial
high-risk children
indigenous
Australia

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014