Evidence map›Paper›PMID 22894958›Full record

Trial reportHuman vaccines & immunotherapeutics2012

Immunogenicity and safety of recombinant tetravalent dengue vaccine (CYD-TDV) in individuals aged 2-45 y: Phase II randomized controlled trial in Singapore.

Yee Sin Leo, Anneliese Wilder-Smith, Sophia Archuleta, Lynette P Shek, Chia-Yin Chong, Hoe Nam Leong, Chian Yong Low, May-Lin Helen Oh, Alain Bouckenooghe, T Anh Wartel and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00880893 (Immunogenicity and Large-Scale Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore), which is not on this map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
13.2field-weighted citation impact, top 1% 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.

NCT00880893 phase2completednot on this map

Immunogenicity and Large-Scale Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2009 to 2014Enrolled1,198ConditionsDengue Fever, Dengue Hemorrhagic Fever, Dengue Virus, Dengue DiseasesArmsCYD Dengue vaccine, NaCl + influenza virus or hepatitis A vaccine
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 91 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Dengue: A Minireview.Viruses · 2020
    Review
  19. Article
  20. 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

11 authors at 9 institutions in 4 countries.

Yee Sin LeoTan Tock Seng Hospital; Singapore.
Anneliese Wilder-Smith
Sophia Archuleta
Lynette P Shek
Chia-Yin Chong
Hoe Nam Leong
Chian Yong Low
May-Lin Helen Oh
Alain Bouckenooghe
T Anh Wartel
Denis Crevat
Sanofi (France) · FRSingapore General Hospital · SGChangi General Hospital · SGKK Women's and Children's Hospital · SGNational University Hospital · SGNational University of Singapore · SGSanofi (Mexico) · MXTan Tock Seng Hospital · SGYong In University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This was a multicenter, blinded, Phase II study (NCT00880893) conducted in Singapore. The primary objectives were to evaluate the safety of a tetravalent dengue vaccine (TDV) comprising four recombinant, live, attenuated viruses (CYD-TDV) and the dengue virus serotype-specific antibody responses before and 28 d after each vaccination. Participants were randomized 3:1 to receive three doses of CYD-TDV or a control vaccine at 0, 6 and 12 mo. Control vaccine was placebo for the first dose (all ages) and for subsequent doses, licensed hepatitis-A for children (aged 2-11 y) or influenza vaccine for adolescents (12-17 y) and adults (18-45 y). Between April and October 2009, 317 children, 187 adolescents and 696 adults were enrolled. In all age groups, reactogenicity was higher after the first injection of CYD-TDV than after placebo control. Reactogenicity after subsequent CYD-TDV doses was no higher than after the first dose, and tended to be lower or similar to that seen after active control vaccination. Seropositivity rates and geometric mean neutralizing antibody titers (GMTs; 1/dil) against all four dengue virus serotypes increased in all age groups after each of the three CYD-TDV doses. Post-dose 3, 66.5% of all participants were seropositive to all four serotypes, and 87.2% were seropositive to ≥ 3 serotypes; GMTs for all participants ranged from 43.0 against dengue virus serotype 1 to 100 against dengue virus serotype 4. GMTs were higher in children than in adolescents. These results support the continued development of CYD-TDV for the prevention of dengue disease.

Indexed as

AdolescentAdultChildChild, PreschoolDengueDengue VaccinesFemaleHumansMaleMiddle AgedSingaporeYoung AdultDengue Vaccines

Identifiers

PMID22894958
PMCPMC3579907
OpenAlexW1996416492

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.