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Using Pneumococcal Vaccines in Combination for Maximum Protection From Ear and Lung Infections in First 3 Years of Life (PREV-IX_B)

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ClinicalTrials.gov Identifier: NCT01735084
Recruitment Status : Enrolling by invitation
First Posted : November 28, 2012
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Menzies School of Health Research

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

HYPOTHESES:

  1. That infants receiving PHiD-CV10 as a booster at 13 months of age, compared to controls having no PHiD-CV10 booster (i.e. standard PCV13), will have higher HiD antibody levels, lower carriage of NTHi, and less tympanic membrane perforation at 18 and 36 months of age.
  2. That infants receiving PCV13 as a booster at 13 months of age, compared to controls having no PCV13 (i.e. PHiD-CV10 booster) will have higher antibody levels to serotypes 3, 6A and 19A, less carriage of these serotypes, and less tympanic membrane perforation at 18 and 36 months of age.

Condition or disease Intervention/treatment Phase
Otitis Media Febrile Illness Cough Lower Respiratory Tract Infection Upper Respiratory Tract Infection Biological: Prevenar13 Biological: Synflorix Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pneumococcal Conjugate Vaccine (PCV) Schedules for the Northern Territory (NT): Randomised Controlled Trial of Booster Vaccines to Broaden and Strengthen Protection From Invasive and Mucosal Infections.
Actual Study Start Date : March 12, 2013
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Prevenar13
The booster dose of Prevenar13 is 0.5 mL given intramuscularly only, with care to avoid injection into or near nerves and blood vessels. The preferred sites are anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in young children.
 Biological: 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).

Other Names:
  • PCV13
  • Prevnar13
Experimental: Synflorix
The booster vaccination schedule consists of one dose of 0.5 ml with an interval of at least 1 month between doses.
 Biological: 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 Names:
  • PHiD-CV
  • PHiD-CV10


Outcome Measures
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Primary Outcome Measures :
  1. Immune response [ Time Frame: At 18 months of age ]
    The primary outcome will be the proportion of subjects with serotype-specific antibody above the level required for protection from IPD in each study group at 18 months of age, 5 months after the booster dose. This will be determined in ELISA assays.


Secondary Outcome Measures :
  1. Nasopharyngeal carriage [ Time Frame: At 13, 18 and 36 months of age ]
    At baseline (13 mo), 18 and 36 months of age, the proportion of children with a any carriage of serotype 3, 6A and 19A pneumococci b any carriage of any NTHi

  2. Otitis media [ Time Frame: At 13, 18 and 36 months of age ]
    At baseline (13 mo), 18 and 36 months of age, the proportion of children with c any otitis media. d any tympanic membrane perforation


Other Outcome Measures:
  1. Episodes of respiratory illness and acute otitis media [ Time Frame: Between baseline (13 mo) and 36 months of age ]
    Between baseline (13 mo) and 36 months of age Episodes of respiratory illness and acute otitis media


Eligibility Criteria
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Ages Eligible for Study:   9 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Australian Indigenous infant who was a participant in PREV-IX_COMBO trial of primary course pneumococcal conjugate vaccines, age at least 2 months post final dose of primary course. Signed informed consent.

Exclusion Criteria:

  • adverse reaction to Prevenar13 or Synflorix
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735084


Locations
Australia, Northern Territory
Menzies School of Health Research
Darwin, Northern Territory, Australia, 0810
Sponsors and Collaborators
Menzies School of Health Research
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Amanda J Leach, PhD Menzies School of Health Research
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT01735084     History of Changes
Other Study ID Numbers: 1046999
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by Menzies School of Health Research:
randomized controlled trial
pneumococcal conjugate vaccines
booster dose
immunogenicity
 nasopharyngeal carriage
Australian Indigenous
pediatric

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Otitis Media
Respiratory Tract Diseases
Otitis
 Ear Diseases
Otorhinolaryngologic Diseases
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs