Trial reportPloS one2013
Altered response to A(H1N1)pnd09 vaccination in pregnant women: a single blinded randomized controlled trial.
Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01012557 (H1N1v Vaccination of Pregnant Women), which is not on this map. Cited by 22 papers, 3 of them syntheses that pooled 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.
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.
H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza AH1N1v Vaccination in Pregnant Women
Who cites it
22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- Pooled it
- Optimal timing of influenza vaccine during pregnancy: A systematic review and meta-analysis.Influenza and other respiratory viruses · 2019Pooled it
- Pooled it
- Trial
- Trial
- Azithromycin for episodes with asthma-like symptoms in young children aged 1-3 years: a randomised, double-blind, placebo-controlled trial.The Lancet. Respiratory medicine · 2016Trial
- Increased dose of H1N1 pandemic influenza vaccine during pregnancy improves immunity in mothers and infants.medRxiv : the preprint server for health sciences · 2025Article
- Article
- Vaccination in pregnant and postpartum women.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2020Article
- Global Perspectives on Immunization During Pregnancy and Priorities for Future Research and Development: An International Consensus Statement.Frontiers in immunology · 2020Review
- Infant airway microbiota and topical immune perturbations in the origins of childhood asthma.Nature communications · 2019Article
- Association of spontaneous abortion with receipt of inactivated influenza vaccine containing H1N1pdm09 in 2010-11 and 2011-12.Vaccine · 2017Article
- Noninvasive Sampling of Mucosal Lining Fluid for the Quantification of In Vivo Upper Airway Immune-mediator Levels.Journal of visualized experiments : JoVE · 2017Article
- Immunological implications of pregnancy-induced microchimerism.Nature reviews. Immunology · 2017Review
- Maternal antibodies protect offspring from severe influenza infection and do not lead to detectable interference with subsequent offspring immunization.Virology journal · 2017Article
- Influenza immunization during pregnancy: Benefits for mother and infant.Human vaccines & immunotherapeutics · 2016Review
- Vaccines, adjuvants and autoimmunity.Pharmacological research · 2015Review
- Enhanced humoral response in pregnant mice immunized with liposome encapsulated recombinant neutralizing epitope protein of Hepatitis- E virus.Virology journal · 2015Article
- Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPregnant women were suspected to be at particular risk when H1N1pnd09 influenza became pandemic in 2009. Our primary objective was to compare the immune responses conferred by MF59®-adjuvanted vaccine (Focetria®) in H1N1pnd09-naïve pregnant and non-pregnant women. The secondary aims were to compare influences of dose and adjuvant on the immune response.
methodsThe study was nested in the Copenhagen Prospective Studies on Asthma in Childhood (COPSAC2010) pregnancy cohort in 2009-2010 and conducted as a single-blinded block-randomised [1∶1∶1] controlled clinical trial in pregnant women after gestational week 20: (1) 7.5 µg H1N1pnd09 antigen with MF59-adjuvant (Pa7.5 µg); (2) 3.75 µg antigen half MF59-adjuvanted (Pa3.75 µg); (3) 15 µg antigen unadjuvanted (P15 µg); and in non-pregnant women receiving (4) 7.5 µg antigen full adjuvanted (NPa7.5 µg). Blood samples were collected at baseline, 3 weeks, 3 and 10 months after vaccination, adverse events were recorded prospectively.
results58 pregnant women were allocated to Pa7.5 µg and 149 non-pregnant women were recruited to NPa7.5 µg. The sero-conversion rate was significantly increased in non-pregnant (NPa7.5 µg) compared with pregnant (Pa7.5 µg) women (OR = 2.48 [1.03-5.95], p = 0.04) and geometric mean titers trended towards being higher, but this difference was not statistically significant (ratio 1.27 [0.85-1.93], p = 0.23). The significant titer increase rate showed no difference between pregnant (Pa7.5 µg) and non-pregnant (NPa7.5 µg) groups (OR = 0.49 [0.13-1.85], p = 0.29).
conclusionOur study suggests the immune response to the 7.5 µg MF59-adjuvanted Focetria® H1N1pnd09 vaccine in pregnant women may be diminished compared with non-pregnant women.
trial registrationClinicalTrials.gov NCT01012557.
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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.