NCT00273325

Brief Summary

Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents the invasive disease from Streptococcus pneumoniae in full-term infants, but was not thoroughly studied in premature infants. This study evaluated the effectiveness and safety of the vaccine given in routine practice to very low birth weight infants, looking at blood antibody levels 4-6 weeks after the final vaccine dose, and adverse events, survival, infections, and neurodevelopmental outcomes at 18-22 months corrected age.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2004

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

September 9, 2005

Last Update Submit

March 20, 2019

Conditions

Pneumococcal InfectionsStreptococcus PneumoniaeInfant, NewbornInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, Premature

Keywords

NICHD Neonatal Research NetworkVery Low Birth Weight (VLBW)Extremely Low Birth Weight (ELBW)PrematurityPneumococcal VaccinesVaccines, ConjugateImmunogenicityVaccine ResponseHeptavalent pneumococcal conjugate vaccine (PCV-7)pneumococcal polysaccharide, type 6BPneumococcal polysaccharide, type 14Pneumococcal polysaccharide, type 19F,Pneumococcal polysaccharide, 23FPneumococcal polysaccharide, 18CPneumococcal polysaccharide, 4Pneumococcal polysaccharide, 9V

Outcome Measures

Primary Outcomes (1)

  • Serotype 6B pneumococcal capsular polysaccharide antibody >=0.15 μg/ml

    4-6 weeks following the third dose of PCV-7

Secondary Outcomes (9)

  • Pneumococcal capsular polysaccharide antibody >=0.15 μg/ml for the other six vaccine serotypes

    4-6 weeks following the third dose of PCV-7

  • Pneumococcal capsular polysaccharide antibodies >=1.0 μg/ml for all seven vaccine serotypes

    4-6 weeks following the third dose of PCV-7

  • Geometric mean titers of pneumococcal capsular polysaccharide antibody to the seven vaccine serotypes

    4-6 weeks following the third dose of PCV-7

  • Pneumococcal capsular polysaccharide antibodies >=0.15 μg/ml and >=1.0 μg/ml, and geometric mean titers of antibody, to the seven vaccine serotypes in children completing the primary series, regardless of postnatal age

    4-6 weeks following the third dose of PCV-7

  • Opsonization of 6B pneumococcal capsular polysaccharide plus 1 low immunogenicity, high prevalence serotype (e.g., 23F) among infants in the lowest quartile of antibody response

    4-6 weeks following the third dose of PCV-7

  • +4 more secondary outcomes

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants \<1,500g birth weight who receive the 3-dose primary series of PCV-7 immunization by 3 months and complete it by 8 months postnatal age

You may qualify if:

  • Gestational age \<32 0/7 weeks
  • Included in Neonatal Research Network Generic Database
  • Family has a telephone at home
  • Anticipated availability for blood draw 4-6 weeks following 3rd vaccine dose
  • Consent obtained before first dose of PCV-7 is given

You may not qualify if:

  • Known immunodeficiency
  • HIV exposure
  • Parental non-consent
  • Primary care pediatrician not willing to participate
  • Enrollment in a conflicting trial
  • Infant has not received first dose of PCV-7 vaccine by 3 months of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Wake Forest University

Charlotte, North Carolina, 27157, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (4)

  • D'Angio CT, Heyne RJ, O'Shea TM, Schelonka RL, Shankaran S, Duara S, Goldberg RN, Stoll BJ, Van Meurs KP, Vohr BR, Das A, Li L, Burton RL, Hastings B, Phelps DL, Sanchez PJ, Carlo WA, Stevenson DK, Higgins RD; NICHD Neonatal Research Network. Heptavalent pneumococcal conjugate vaccine immunogenicity in very-low-birth-weight, premature infants. Pediatr Infect Dis J. 2010 Jul;29(7):600-6. doi: 10.1097/INF.0b013e3181d264a6.

    PMID: 20234331RESULT

  • Wynn JL, Li L, Cotten CM, Phelps DL, Shankaran S, Goldberg RN, Carlo WA, Van Meurs K, Das A, Vohr BR, Higgins RD, Stoll BJ, D'Angio CT. Blood stream infection is associated with altered heptavalent pneumococcal conjugate vaccine immune responses in very low birth weight infants. J Perinatol. 2013 Aug;33(8):613-8. doi: 10.1038/jp.2013.5. Epub 2013 Jan 31.

    PMID: 23370608RESULT

  • Ang JY, Lua JL, Asmar BI, Shankaran S, Heyne RJ, Schelonka RL, Das A, Li L, Jackson DM, Higgins RD, D'Angio CT; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Nasopharyngeal carriage of Streptococcus pneumoniae in very low-birth-weight infants after administration of heptavalent pneumococcal conjugate vaccine. Arch Pediatr Adolesc Med. 2010 Dec;164(12):1173-5. doi: 10.1001/archpediatrics.2010.233. No abstract available.

    PMID: 21135351RESULT

  • D'Angio CT, Murray TE, Li L, Heyne RJ, O'Shea TM, Schelonka RL, Shankaran S, Duara S, Goldberg RN, Stoll BJ, Stevenson DK, Vohr BR, Phelps DL, Carlo WA, Pichichero ME, Das A, Higgins RD; NICHD Neonatal Research Network. Immunogenicity of Haemophilus influenzae type b protein conjugate vaccines in very low birth weight infants. Pediatr Infect Dis J. 2013 Dec;32(12):1400-2. doi: 10.1097/01.inf.0000437263.04493.7c. No abstract available.

    PMID: 24569312RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Serum was separated from blood samples. After all study assays were completed on all subjects, if a subject's parents asked that his/her serum not be stored, the serum was destroyed. For subjects whose parents permit it, leftover serum was re-labeled with a new, randomly-generated unique de-identifier, linked only to the subject's gestational age, birth weight, and chronologic age at the time of sampling. The link to any other subject identifiers will then be destroyed. The serum will be stored indefinitely at the University of Rochester for other, non-genetic-testing-related research.

MeSH Terms

Conditions

Pneumococcal InfectionsPremature Birth

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ronald N. Goldberg, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Barbara J. Stoll, MD

    Emory University

    PRINCIPAL INVESTIGATOR

  • Abhik Das, PhD

    RTI International

    PRINCIPAL INVESTIGATOR

  • Krisa P. Van Meurs, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Waldemar A. Carlo, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • Shahnaz Duara, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

  • Carl T. D'Angio, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

  • Pablo J. Sanchez, MD

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

  • T. Michael O'Shea, MD MPH

    Wake Forest University

    PRINCIPAL INVESTIGATOR

  • Seetha Shankaran, MD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

January 9, 2006

Study Start

July 1, 2004

Primary Completion

July 1, 2007

Study Completion

March 1, 2009

Last Updated

March 22, 2019

Record last verified: 2019-03

Locations

US(10)