Gardasil trial stopped in India after 4 girls aged 10-14 die/ dnaIndia

According to DNAIndia,

... The programme was marred by controversy after four deaths and complications among 120 girls were reported after vaccination. The girls complained of stomach disorders, epilepsy, headaches and early menarche...

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Dr. Katoch said a memorandum was signed with PATH-International in February 2007 for a project allotted to it by the Bill and Melinda Gates Foundation for assessing the feasibility of introducing HPV vaccine in India. Merck and GSK were to provide the vaccine and ICMR helped in protocol preparation.

Initially, the NGO conducted a survey of the social acceptability of the project with the help of a questionnaire among the socially disadvantaged groups, as cervical cancer occurred more among the women from the disadvantaged sections with less health facilities and low-capacity for buying expensive drugs. By the time the trial ended, the Drugs-Controller of India gave approval for marketing the two vaccines.

Pointing out that the trial started after approval from the State Advisory Committees and the ethical committees of the Andhra Pradesh and Gujarat governments and the National Technical Advisory Group as per the agreement with the NGOs, Dr. Katoch said: “Everything was going fine until we received complaints of violation of guidelines and exploitation of people from civil society groups some months ago following the death of four girls, who were given this vaccine.”