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 :
Completed
First Posted : November 28, 2012
Last Update Posted : March 25, 2020
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HYPOTHESES:
- That infants receiving PHiD-CV10 as a booster at 12 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.
- That infants receiving PCV13 as a booster at 12 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 |
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Otitis Media Febrile Illness Cough Lower Respiratory Tract Infection Upper Respiratory Tract Infection | Biological: Prevenar13 Biological: Synflorix | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 261 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 |
Actual Primary Completion Date : | February 14, 2019 |
Actual Study Completion Date : | October 3, 2019 |
Arm | Intervention/treatment |
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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.
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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:
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Experimental: Synflorix
The booster vaccination schedule consists of one dose of 0.5 ml with an interval of at least 1 month between doses.
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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:
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- 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, 6 months after the booster dose. This will be determined in ELISA assays.
- Nasopharyngeal carriage [ Time Frame: At 12, 18 and 36 months of age ]At baseline (12 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
- Otitis media [ Time Frame: At 12, 18 and 36 months of age ]At baseline (12 mo), 18 and 36 months of age, the proportion of children with c any otitis media. d any tympanic membrane perforation
- Episodes of respiratory illness and acute otitis media [ Time Frame: Between baseline (12 mo) and 36 months of age ]Between baseline (12 mo) and 36 months of age Episodes of respiratory illness and acute otitis media

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

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
Australia, Northern Territory | |
Menzies School of Health Research | |
Darwin, Northern Territory, Australia, 0810 |
Principal Investigator: | Amanda J Leach, PhD | Menzies School of Health Research |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Menzies School of Health Research |
ClinicalTrials.gov Identifier: | NCT01735084 |
Other Study ID Numbers: |
1046999 |
First Posted: | November 28, 2012 Key Record Dates |
Last Update Posted: | March 25, 2020 |
Last Verified: | March 2020 |
randomized controlled trial pneumococcal conjugate vaccines booster dose immunogenicity |
nasopharyngeal carriage Australian Indigenous pediatric |
Infections Communicable Diseases Respiratory Tract Infections Otitis Media Disease Attributes Pathologic Processes Respiratory Tract Diseases |
Otitis Ear Diseases Otorhinolaryngologic Diseases Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |