Evidence map›Paper›PMID 25444821›Full record

Trial reportVaccine2014

Maternal immunization with pneumococcal 9-valent conjugate vaccine and early infant otitis media.

Kathleen A Daly, G Scott Giebink, Bruce R Lindgren, JoAnn Knox, Betty Jo Haggerty, James Nordin, Sarah Goetz, Patricia Ferrieri

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Maternal vaccination: a review of current evidence and recommendations.American journal of obstetrics and gynecology · 2022
    Review
  4. Article
  5. Article
  6. Effect of Maternally Derived Anti-protein and Anticapsular IgG Antibodies on the Rate of Acquisition of Nasopharyngeal Carriage of Pneumococcus in Newborns.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Article
  7. Panel 6: Vaccines.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2017
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Kathleen A DalyDepartment of Otolaryngology, University of Minnesota Medical School, Minneapolis, MN, USA.
G Scott GiebinkDepartment of Otolaryngology, University of Minnesota Medical School, Minneapolis, MN, USA; Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.
Bruce R LindgrenMasonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
JoAnn KnoxDepartment of Otolaryngology, University of Minnesota Medical School, Minneapolis, MN, USA.
Betty Jo HaggertyHealthPartners Research Foundation, Minneapolis, MN, USA.
James NordinHealthPartners Research Foundation, Minneapolis, MN, USA.
Sarah GoetzDepartment of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.
Patricia FerrieriDepartment of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA; Department of Laboratory Medicine and Pathology, University of Minnesota Medical School, Minneapolis, MN, USA. Electronic address: ferri002@umn.edu.
University of Minnesota Medical Center · USHealthPartners · US

Funding

MATERNAL IMMUNIZATION TO PREVENT INFANT OTITIS MEDIAR01DC005974 · NIDCD · UNIVERSITY OF MINNESOTA TWIN CITIES · PI FERRIERI, PATRICIA · 2003 to 2005
$3.2M
OTITIS MEDIA CLINICAL RESEARCH CENTERP50DC003093 · NIDCD · UNIVERSITY OF MINNESOTA TWIN CITIES · PI GIEBINK, G. SCOTT · 1996 to 2002
$2.5M
NIDCD NIH HHS P50 DC03093NIDCD NIH HHS P50 DC03093-05S1NIDCD NIH HHS R01 DC005974
6 · The paper itself

Abstract

A randomized trial of an investigational 9-valent pneumococcal conjugate vaccine (PCV-9) or placebo given to pregnant women during the last trimester to prevent early infant otitis media (OM) was conducted. All infants received Prevnar(®) at 2, 4, 6, and 12 months. Clinic and adverse event records were reviewed to identify OM. Variables significantly related to acute OM by age 6 months (p<0.05) were: vaccine group (9 valent or placebo), sibling history of tympanostomy tubes, upper respiratory infection, and number of clinic visits by 6 months. Infant OM rates were similar between 6 and 12 months (58% and 56%). Results suggested that immunizing pregnant women with PCV-9 increased infants' risk of acute OM in the first 6 months of life, and this correlated with decreased infant antibody responses to their infant Streptococcus pneumoniae vaccine serotypes, but did not influence antibody responses to 3 other serotypes two of which were in maternal vaccine (types 1 and 5) and one was a control (type 7F). Explanations for these results include dampening of infant antibody production by high levels of passively acquired maternal pneumococcal antibodies and/or altered B lymphocyte immune responses in infants exposed to these specific polysaccharide antigens in utero.

Indexed as

Immunity, Maternally-AcquiredAdultFemaleHumansImmunizationIncidenceInfantInfant, NewbornMaleOtitis MediaPlacebosPneumococcal InfectionsPneumococcal VaccinesPregnancyTreatment OutcomeVaccines, ConjugatePlacebosPneumococcal VaccinesVaccines, ConjugateMaternal immunizationOtitis mediaPneumococcal antibodiesPneumococcus

Identifiers

PMID25444821
PMCPMC4272011
OpenAlexW1976046230

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.