Clinical trial · Interventional
Effectiveness of Cervical Screening in HPV Vaccinated Women
Effectiveness of Cervical Screening in HPV Vaccinated Women - a Randomized Trial
NCT02149030CI-TRIAL-00084892HPV-004active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of the study is to identify whether or not being informed infrequently results about screening is: 1) At least as safe and accurate as frequently obtaining all information from the present combination of opportunistic/organized cervical screening by comparing regimen results of three screening visits at the ages of 22, 25 and 30 years (Arm A1) vs. results of one screening visit at the age of 30 years (Arm A2) in Human papillomavirus (HPV) vaccinated young women.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia Grade 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytological screening in A1 and A3 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- A1
- description
- A1) Cytological screening in A1 and A3. Frequent information of screening results for cytology and/or HPV DNA at the ages of 22 (cytology only), 25 and 30.
- interventionNames
- Other: Cytological screening in A1 and A3
- type
- NO_INTERVENTION
- label
- A2
- description
- A2) infrequent information of screening results, only at the age 30 years.
- type
- OTHER
- label
- A3
- description
- A3) Cytological screening in A1 and A3. With at least 1000 participants is enrolled for interim safety analysis when the 1992 birth cohort is 25 years of age and cytology results are being revealed.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 22 Years
- Maximum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * HPV 16/18 vaccinated. Born 1992-1995. Exclusion Criteria: * Immunocompromising disease. HPV 6/11/16/18 vaccination.
References
Publications (12)
- BACKGROUNDVanska S, Luostarinen T, Baussano I, Apter D, Eriksson T, Natunen K, Nieminen P, Paavonen J, Pimenoff VN, Pukkala E, Soderlund-Strand A, Dubin G, Garnett G, Dillner J, Lehtinen M. Vaccination With Moderate Coverage Eradicates Oncogenic Human Papillomaviruses If a Gender-Neutral Strategy Is Applied. J Infect Dis. 2020 Aug 17;222(6):948-956. doi: 10.1093/infdis/jiaa099. PMID 32161969
- BACKGROUNDLouvanto K, Eriksson T, Gray P, Apter D, Baussano I, Bly A, Harjula K, Heikkila K, Hokkanen M, Huhtinen L, Ikonen M, Karttunen H, Nummela M, Soderlund-Strand A, Veivo U, Dillner J, Elfstom M, Nieminen P, Lehtinen M. Baseline findings and safety of infrequent vs. frequent screening of human papillomavirus vaccinated women. Int J Cancer. 2020 Jul 15;147(2):440-447. doi: 10.1002/ijc.32802. Epub 2019 Dec 16. PMID 31749143
- BACKGROUNDGray P, Kann H, Pimenoff VN, Eriksson T, Luostarinen T, Vanska S, Surcel HM, Faust H, Dillner J, Lehtinen M. Human papillomavirus seroprevalence in pregnant women following gender-neutral and girls-only vaccination programs in Finland: A cross-sectional cohort analysis following a cluster randomized trial. PLoS Med. 2021 Jun 7;18(6):e1003588. doi: 10.1371/journal.pmed.1003588. eCollection 2021 Jun. PMID 34097688
- BACKGROUNDKalliala I, Eriksson T, Aro K, Hokkanen M, Lehtinen M, Gissler M, Nieminen P. Preterm birth rate after bivalent HPV vaccination: Registry-based follow-up of a randomized clinical trial. Prev Med. 2021 May;146:106473. doi: 10.1016/j.ypmed.2021.106473. Epub 2021 Feb 24. PMID 33639181
- BACKGROUNDLehtinen M, Gray P, Louvanto K, Vanska S. In 30 years, gender-neutral vaccination eradicates oncogenic human papillomavirus (HPV) types while screening eliminates HPV-associated cancers. Expert Rev Vaccines. 2022 Jun;21(6):735-738. doi: 10.1080/14760584.2022.2064279. Epub 2022 Apr 15. No abstract available. PMID 35404177
- BACKGROUNDLehtinen M, Pimenoff VN, Nedjai B, Louvanto K, Verhoef L, Heideman DAM, El-Zein M, Widschwendter M, Dillner J. Assessing the risk of cervical neoplasia in the post-HPV vaccination era. Int J Cancer. 2023 Mar 15;152(6):1060-1068. doi: 10.1002/ijc.34286. Epub 2022 Oct 10.