Mother's Gift Project | NCT00142389

Studies
Mother's Gift Project

NCT00142389

Sponsor

Johns Hopkins Bloomberg School of Public Health

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

680

Phase

Phase 1Phase 2

Conditions

Pneumococcal Infections

Interventions

pneumococcal polysaccharide and protein conjugate vaccines

Countries

Bangladesh

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Sep 1, 2005

First Submission Date that Met QC Criteria

Sep 1, 2005

First Posted Date

Sep 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Johns Hopkins Bloomberg School of Public HealthOTHER

Collaborators

Name	Class
Thrasher Research Fund	OTHER
Bill and Melinda Gates Foundation	OTHER
United States Agency for International Development (USAID)	FED
Wyeth is now a wholly owned subsidiary of Pfizer

Description Module

Brief Summary

This prospective randomized evaluation of pneumococcal vaccine immunization of pregnant mothers, followed by pneumococcal conjugate immunization of their children is designed to assess the effects of these strategies on the immunogenicity and safety of both vaccines. We hypothesize that maternal followed by infant immunization will be safe and will provide higher levels of antibody from birth through 12 months of age.

Detailed Description

This is a randomized vaccine evaluation in 4 groups of mothers and their infants, to assess the effect of maternal immunization on the infants' response to pneumococcal vaccine.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

680

Name	Type	Description	Arm Group Labels	Other Names
pneumococcal polysaccharide and protein conjugate vaccines	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age
local and systemic reactions within 2 weeks of vaccination

Secondary Outcomes

Measure	Description	Time Frame
Level and duration of serum IgG antibody to pneumococcus up to 1 year of age.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mothers from 18 to 14 years of age in the third trimester of pregnancy,
with normal medical and obstetric history,
who plan to deliver their infant in Dhaka city and remain there for 12m

Exclusion Criteria:

Maternal history of systemic disease,
Maternal history of previous complicated pregnancies, preterm delivery, abortions, or birth with congenital anomalies.
Maternal hypersensitivity to any vaccination, or
Maternal receipt of pneumococcal vaccine in the last 3 years.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
M C Steinhoff, MD	Johns Hopkins Bloomberg School of Public Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ICDDRB		Dhaka			Bangladesh

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23967126	Derived	Schlaudecker EP, Steinhoff MC, Omer SB, McNeal MM, Roy E, Arifeen SE, Dodd CN, Raqib R, Breiman RF, Zaman K. IgA and neutralizing antibodies to influenza a virus in human milk: a randomized trial of antenatal influenza immunization. PLoS One. 2013 Aug 14;8(8):e70867. doi: 10.1371/journal.pone.0070867. eCollection 2013.
23300160

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses