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Immunogenicity of 3+1 Versus 2+1 Schedule for PCV7

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ClinicalTrials.gov Identifier: NCT02040402
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : January 20, 2014
Sponsor:
Collaborator:
The Society for the Relief of Disabled Children, Hong Kong
Information provided by (Responsible Party):
Lau Yu Lung, The University of Hong Kong

Brief Summary:

Pneumonia is one of the most prevalent diseases in infants and children. The incidence of pneumonia in children less than 5 years old is about 34-40 cases per 1000 in Europe and America and more than 2 million children die of pneumonia annually. It was reported that Streptococcus pneumoniae accounted for 13%-53% of lower respiratory tract infections in different age group of infants or children. In addition, 7%-9% of bacterial meningitis was due to Streptococcus pneumoniae infection. In addition, children infected with Streptococcus pneumoniae often transmit the pathogens to adult. As a result, it is evident that Streptococcus pneumoniae presents a heavy burden to paediatrics practice.

Vaccination of 7-valent pneumococcal conjugate vaccines is effective in preventing Streptococcus pneumonia .Routine use of PCV7 in the US has rapidly reduced rates of invasive pneumococcal disease in children. The impact of the vaccine was noted within 1 year of introduction. According to Centre for Disease Control's (CDC) Active Bacterial Core Surveillance (ABCs) the incidence of invasive pneumococcal disease among children <5 years dropped 75% from 1998/1999 to 2005; disease caused by vaccine-type strains fell 94% from 80 to 4.6 per 100,000. Currently there are two immunization schedules: manufacturer recommended the 3+1 schedule and many countries adopted a 3 dose schedule, either 3+0 or 2+1 schedules. In US, it is recommended to give three doses during infancy (scheduled at 2, 4, 6 month) plus one dose at 12-15 months (3+1 schedule). Since several studies have demonstrated that two doses may provide similar direct protection to three conjugate doses during infancy, it is recommended to give two doses during infancy plus a booster dose 12 months in some European countries including United Kingdom.

In this trial, the immunogenicity of the 3+1 schedule and the 2+1 schedule of 7-valent pneumococcal conjugated vaccine in young infants will be compared.


Condition or disease Intervention/treatment Phase
Infectious Disease Biological: 7-valent pneumococcal conjugated vaccine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of the Immunogenicity of the 3+1 Schedule and the 2+1 Schedule of 7-valent Pneumococcal Conjugated Vaccine in Young Chinese Infants
Study Start Date : February 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Active Comparator: 4-Dose Regimen

3+1 schedule of 7-valent pneumococcal conjugated vaccine:

Infants who are randomized for 3+1 schedule will be administrated one dose of PCV7 at the age of 2 months old, 4months old and 6 months old. A booster dose will be administrated at the age of 12 months old.

Infants will be followed up for 12-16 months starting from vaccination of first dose. There is no restriction on the use of other medications before or during the follow-up period.

Biological: 7-valent pneumococcal conjugated vaccine
3+1 doses vs 2+1 doses

Active Comparator: 3-Dose Regimen

2+1 schedule of 7-valent pneumococcal conjugated vaccine:

Infants who are randomized for 2+1 schedule will be administrated with one dose of PCV7 at the age of 2 months old and 4months old. A booster dose will be administrated at the age of 12 months old.

Infants will be followed up for 12-16 months starting from vaccination of first dose. There is no restriction on the use of other medications before or during the follow-up period.

Biological: 7-valent pneumococcal conjugated vaccine
Pneumococcal vaccine 3+1 and 2+1 schedule comparison




Primary Outcome Measures :
  1. Serological response in terms of geometric mean titres after the primary dose series and booster for the 2+1 and 3+1 schedules. [ Time Frame: An average of one month post vaccination ]

Secondary Outcome Measures :
  1. Proportion of infants with Immunoglobulin G concentrations above 0.35ug/ml to the 7 serotypes [ Time Frame: An average of one month post vaccination ]


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Ages Eligible for Study:   6 Weeks to 9 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Chinese infants born in Hong Kong

Exclusion Criteria:

(i)Previous administration of PCV7 or other pneumococcal vaccines

(ii)History of immunodeficiency

(iii)Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment

(iv)Malignancy, other than squamous cell or basal cell skin cancer

(v)Autoimmune disease

(vi)History of asthma or reactive airways disease

(vii)Cardiovascular and pulmonary disorder, chronic metabolic disease (including diabetes), renal dysfunction or hemoglobinopathies requiring regular medical follow-up or hospitalization during the preceding year

(viii)Use of immunosuppressive medication

(ix)Receipt of blood products or immunoglobulin in the past 6 month


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): NCT02040402


Locations
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China, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
The Society for the Relief of Disabled Children, Hong Kong
Investigators
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Principal Investigator: Yu-lung LAU, MD The University of Hong Kong

Publications:

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Responsible Party: Lau Yu Lung, Chair Professor of Paediatrics, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02040402     History of Changes
Other Study ID Numbers: UW 09-024
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: January 20, 2014
Last Verified: January 2014

Keywords provided by Lau Yu Lung, The University of Hong Kong:
Comparison of pneumococcal conjugated vaccine regimes

Additional relevant MeSH terms:
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Communicable Diseases
Infection
Vaccines
Immunologic Factors
Physiological Effects of Drugs